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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K862801
Device Name SPUNGUARD PLUS SURGICAL DRAPE
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 Number878.4370
Classification Product Code
KKX  
Date Received07/23/1986
Decision Date 08/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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