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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
510(k) Number K893987
Device Name NIDEK MODEL YC-1200
Applicant
NIDEK, INC.
CRC ASSOCIATES
25422 TRABUCO ROAD#105-253
EL TORO,  CA  92630
Applicant Contact JANET MCCOMB
Correspondent
NIDEK, INC.
CRC ASSOCIATES
25422 TRABUCO ROAD#105-253
EL TORO,  CA  92630
Correspondent Contact JANET MCCOMB
Regulation Number886.4392
Classification Product Code
LXS  
Date Received06/05/1989
Decision Date 08/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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