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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 K881471
Device Name KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact CYNTHIA E SMITH
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact CYNTHIA E SMITH
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/07/1988
Decision Date 08/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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