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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K883213
Device Name NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
Applicant
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Applicant Contact BRADLEY DONALDSON
Correspondent
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Correspondent Contact BRADLEY DONALDSON
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/29/1988
Decision Date 09/15/1988
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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