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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 K932036
Device Name LACERATION TRAY
Applicant
CLINIPAD CORP.
66 HIGH ST.
P.O. BOX 387
GUILFORD,  CT  06437
Applicant Contact PATRICIA STAWARZ
Correspondent
CLINIPAD CORP.
66 HIGH ST.
P.O. BOX 387
GUILFORD,  CT  06437
Correspondent Contact PATRICIA STAWARZ
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
KDD  
Date Received04/27/1993
Decision Date 12/13/1993
Decision Substantially Equivalent - Kit (SESK)
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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