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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 SOUTH UNION BLVD.
STE. G-160
LAKEWOOD,  CO  80228 -2207
Applicant Contact ALLEN, PHD
Correspondent
ELANTEC, INC.
85 SOUTH UNION BLVD.
STE. G-160
LAKEWOOD,  CO  80228 -2207
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
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