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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 K894437
Device Name PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH
Applicant
Clive Craig Co.
8894 Regent St.
Los Angeles,  CA  90034
Applicant Contact PAUL WITTROCK
Correspondent
Clive Craig Co.
8894 Regent St.
Los Angeles,  CA  90034
Correspondent Contact PAUL WITTROCK
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/17/1989
Decision Date 01/10/1990
Decision Substantially Equivalent (SESE)
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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