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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 K953879
Device Name SURGEON'S CAP
Applicant
American Threshold Industries, Inc.
240 Sardis Rd.
P.O. Box 1209
Enka,  NC  28728
Applicant Contact GREGORY B SCOTT
Correspondent
American Threshold Industries, Inc.
240 Sardis Rd.
P.O. Box 1209
Enka,  NC  28728
Correspondent Contact GREGORY B SCOTT
Regulation Number878.4040
Classification Product Code
FYF  
Date Received08/16/1995
Decision Date 01/05/1996
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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