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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K950850
Device Name GENT-L-KARE LACERATION TRAYS
Applicant
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Applicant Contact GARY GARBIN
Correspondent
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Correspondent Contact GARY GARBIN
Regulation Number880.6850
Classification Product Code
FRG  
Date Received02/24/1995
Decision Date 03/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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