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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K903544
Device Name CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
Applicant
J.J. Skinner, Inc.
C/O Medical Device Inspection
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
J.J. Skinner, Inc.
C/O Medical Device Inspection
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number878.4800
Classification Product Code
LRP  
Date Received08/06/1990
Decision Date 08/31/1990
Decision Substantially Equivalent - With Drug (SESD)
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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