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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 K930632
Device Name CHEMOSITE IMPLANTABLE DRUG DELIVERY
Applicant
Device Labs, Inc.
3 Industrial Park Rd.
Medway,  MA  02053
Applicant Contact ELTON M TUCKER
Correspondent
Device Labs, Inc.
3 Industrial Park Rd.
Medway,  MA  02053
Correspondent Contact ELTON M TUCKER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/08/1993
Decision Date 12/22/1993
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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