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DEC 14 200o 5 10(k) SUMMARY OF SAFETY AND EFFECTIVENESS Air-Flex with Auto-Distraction 1. Submitter's Name and Address 1.1 1.2 1.3 2. Name: Title: Telephone: Facsimile: E-mail: Brady Allen Sales/Service

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1. Manufacturers or distributors of home medical devices must adhere to FDA regulations and guidelines.
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