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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 K930840
Device Name POST-MYDS(TM)
Applicant
AUKLAND MEDICAL PLASTICS, INC.
P.O. BOX 5624
CARY,  NC  27512
Applicant Contact NORMAN A GRAY
Correspondent
AUKLAND MEDICAL PLASTICS, INC.
P.O. BOX 5624
CARY,  NC  27512
Correspondent Contact NORMAN A GRAY
Regulation Number886.4750
Classification Product Code
HOY  
Date Received02/17/1993
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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