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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tong, Skull For Traction
510(k) Number K915530
Device Name NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
Applicant
American Threshold Industries, Inc.
240 Sardis Rd.
P.O. Box 1209
Enka,  NC  28728
Applicant Contact ROBERT T BAYER
Correspondent
American Threshold Industries, Inc.
240 Sardis Rd.
P.O. Box 1209
Enka,  NC  28728
Correspondent Contact ROBERT T BAYER
Regulation Number882.5960
Classification Product Code
HAX  
Date Received12/10/1991
Decision Date 08/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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