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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 K895293
Device Name KEMI LABS - ADHESIVE BANDAGE REMOVER
Applicant
Kemi Labs, Inc.
91 Oak Bluff Rd.
Milford,  CT  06460
Applicant Contact TOM SNELL
Correspondent
Kemi Labs, Inc.
91 Oak Bluff Rd.
Milford,  CT  06460
Correspondent Contact TOM SNELL
Regulation Number878.4730
Classification Product Code
KOX  
Date Received08/25/1989
Decision Date 02/09/1990
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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