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Premarket Notification -Guangzhou 510(k) SUMMARY AS REQUIRED BY SECTION 807.92©Wonder Biotech Co. Ltd. K23 AUG 2 5 2010 1. Date the summary was prepared: August 18, 2010, Address: Guangzhou Wonder
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Submitter's contact information for reporting: Phone: Fax: Email: Howard Mann 5. The name of the person to whom the summary is addressed: Howard Mann Sheryl Sherbets Associates 6. The nature of the incident: Incident occurred on August 17, 2010, at 23:30, at a location in Guangzhou, Guangdong province, China. 7. What type of material contained in the violation: (i) The products that were subject to the summary were (a) the following drugs: (1) DAN (epinephrine injector and inhaler) [EPI] and (2) WBS (doxycycline, Riboviria, Zithromax, and cefuroxime), (b) other chemicals, including “non-intoxicating” water soluble ingredients, (c) substances having the chemical formula: C3H9NO2, CN (Cl — OH), CH 2 OH, or any combination thereof, used in connection with the manufacture of the products and (3) pharmaceutical grade non-volatile fluids used in a pharmaceutical, biological (human and veterinary) or non-pharmaceutical purpose, not intended to be taken internally or externally, and (4) other substances and their mixtures, including mixtures containing substances and mixtures containing mixtures of substances not elsewhere classified. (ii) Byproducts formed during the manufacture of the products. SOURCE: Cite as: US Department of Agriculture. OCR Violations: General.

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Guangzhou Wondfo Biotech Co., Ltd. is a biotechnology company based in Guangzhou, China.
Guangzhou Wondfo Biotech Co. is required to file their own company reports.
To fill out Guangzhou Wondfo Biotech Co. reports, you can refer to the official guidelines provided by the relevant regulatory authorities.
The purpose of Guangzhou Wondfo Biotech Co. is to develop, manufacture, and distribute biotech products, services, and solutions.
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