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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solvent, Adhesive Tape
510(k) Number K902009
Device Name ELANTEC'S SURGICAL TAPE REMOVER
Applicant
Elantec, Inc.
85 S. Union Blvd.
Suite G-160
Lakewood,  CO  80228
Applicant Contact ALLEN, PHD
Correspondent
Elantec, Inc.
85 S. Union Blvd.
Suite G-160
Lakewood,  CO  80228
Correspondent Contact ALLEN, PHD
Regulation Number878.4730
Classification Product Code
KOX  
Date Received05/03/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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