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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cap, surgical
510(k) Number K863359
Device Name BOUFFANT-STYLE SURGICAL CAP
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact CYNTHIA SMITH
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact CYNTHIA SMITH
Regulation Number878.4040
Classification Product Code
FYF  
Date Received09/02/1986
Decision Date 09/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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