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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 K885321
Device Name WATER JEL STERILE GEL-SOAKED BURN DRESSING
Applicant
Pfizer Pharmaceuticals
235 E. 42nd St.
Ny,  NY  10017
Applicant Contact DAVID OPPENHEIMER
Correspondent
Pfizer Pharmaceuticals
235 E. 42nd St.
Ny,  NY  10017
Correspondent Contact DAVID OPPENHEIMER
Classification Product Code
FRO  
Date Received12/28/1988
Decision Date 03/22/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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