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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 K980989
Device Name 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
Applicant
Innovative Technologies , Ltd.
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Applicant Contact ANNA E MCRIGHT
Correspondent
Innovative Technologies , Ltd.
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Correspondent Contact ANNA E MCRIGHT
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/16/1998
Decision Date 05/27/1998
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
Predetermined Change
Control Plan Authorized		 No
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