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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K781019
Device Name SURG. GOWN & DRAPE, LOW LINT TREATMENT
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 Number878.3500
Classification Product Code
KKY  
Date Received01/16/1978
Decision Date 08/14/1978
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
Predetermined Change
Control Plan Authorized		 No
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