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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K905439
Device Name HYPERGEL PROTECTIVE WOUND GEL
Applicant
SCOTT HEALTH CARE
SCOTT PLAZA III
PHILADELPHIA,  PA  19113 -1585
Applicant Contact RICHARD HAMER
Correspondent
SCOTT HEALTH CARE
SCOTT PLAZA III
PHILADELPHIA,  PA  19113 -1585
Correspondent Contact RICHARD HAMER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/04/1990
Decision Date 05/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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