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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, measuring, lens radius, ophthalmic
510(k) Number K930437
Device Name MARCO STANDARD RADIUSGAUGES
Applicant
MARCO OPHTHALMIC, INC.
11825 CENTRAL PKWY.
JACKSONVILLE,  FL  32224
Applicant Contact WAYNE STARLING
Correspondent
MARCO OPHTHALMIC, INC.
11825 CENTRAL PKWY.
JACKSONVILLE,  FL  32224
Correspondent Contact WAYNE STARLING
Regulation Number886.1430
Classification Product Code
HLF  
Date Received01/26/1993
Decision Date 08/09/1993
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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