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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 K844197
Device Name ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
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 Received10/30/1984
Decision Date 12/24/1984
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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