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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 K982818
Device Name HOSPAL TIPSTOP
Applicant
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
GAMBRO HEALTHCARE
1185 OAK ST.
LAKEWOOD,  CO  80215 -4498
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received08/11/1998
Decision Date 10/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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