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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gown, surgical
510(k) Number K981393
Device Name MICROCOOL SURGICAL GOWN
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact LARRY R KLUDT
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact LARRY R KLUDT
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
FYC  
Date Received04/17/1998
Decision Date 07/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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