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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photocoagulator and accessories
510(k) Number K860011
Device Name NIDEK AC-2000 LASER SYSTEM
Applicant
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Applicant Contact JOHN BRATKOWSKY
Correspondent
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Correspondent Contact JOHN BRATKOWSKY
Regulation Number886.4690
Classification Product Code
HQB  
Date Received01/03/1986
Decision Date 02/07/1986
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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