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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 K935199
Device Name SURGICAL APPAREL
Applicant
ASSOCIATED HOSPITAL SERVICES, INC.
7639 TOWNSEND PLACE
NEW ORLEANS,  LA  70126
Applicant Contact LOU SCHULTZ
Correspondent
ASSOCIATED HOSPITAL SERVICES, INC.
7639 TOWNSEND PLACE
NEW ORLEANS,  LA  70126
Correspondent Contact LOU SCHULTZ
Regulation Number878.3500
Classification Product Code
KKY  
Subsequent Product Code
FYA  
Date Received10/27/1993
Decision Date 09/30/1994
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
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