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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 K803293
FOIA Releasable 510(k) K803293
Device Name GUARDIAN PEEL POUCHES
Applicant
KIMBERLY-CLARK CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KIMBERLY-CLARK CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/30/1980
Decision Date 01/28/1981
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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