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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K832407
Device Name DECUBITUS CARE ABSORBENT DRESSING
Applicant
American Pharmaseal Div. Ahsc
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Pharmaseal Div. Ahsc
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
FRO  
Date Received07/21/1983
Decision Date 01/19/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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