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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 K801336
Device Name MODEL 900K PHOTOCOAGULATOR
Applicant
COHERENT MEDICAL DIVISION
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
COHERENT MEDICAL DIVISION
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/04/1980
Decision Date 07/28/1980
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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