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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 Rd.#105-253
El Toro,  CA  92630
Applicant Contact JANET MCCOMB
Correspondent
Nidek, Inc.
Crc Associates
25422 Trabuco Rd.#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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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