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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 K843300
Device Name SKIN-LITE
Applicant
Guardian Chemical
P.O. Box 2500
Smithtown,  NY  11787
Applicant Contact ROBERT S RUBINGER
Correspondent
Guardian Chemical
P.O. Box 2500
Smithtown,  NY  11787
Correspondent Contact ROBERT S RUBINGER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received08/23/1984
Decision Date 11/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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