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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. Raymond Kelly IV Licensale Inc. 57 Lazy Brook Rd. Monroe Connecticut 06468 Re K150219 Trade/Device Name Equashield Closed System drug Transfer Device CSTD Regulation Number 21 CFR 880. 5440 Regulatory Class II Product Code ONB Dated September 25 2015 Received September 29 2015 Dear Mr. Type of Use Select one or both as...

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1. Healthcare institutions and hospitals that handle hazardous drugs.
2. Pharmaceutical manufacturers or distributors involved in the transportation and handling of hazardous drugs.
3. Medical professionals and practitioners who administer or use hazardous drugs in their practice.
4. Workers or technicians who are responsible for compounding or handling hazardous drugs.
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What is equashield medical ltd?

Equashield Medical Ltd is a medical technology company that specializes in providing closed system transfer devices for safe handling of hazardous drugs.

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