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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K934085
Device Name MODIFICATION OF SURGICAL EYESHIELD MASK
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 Number886.4750
Classification Product Code
HOY  
Date Received08/20/1993
Decision Date 11/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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