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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
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