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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 K862568
Device Name LDS - LASER DELIVERY SYSTEM
Applicant
COHERENT MEDICAL GROUP
3270 W. BAYSHORE RD.
P.O. BOX 10122
PALO ALTO,  CA  94303
Applicant Contact ALAN L VOSS
Correspondent
COHERENT MEDICAL GROUP
3270 W. BAYSHORE RD.
P.O. BOX 10122
PALO ALTO,  CA  94303
Correspondent Contact ALAN L VOSS
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/07/1986
Decision Date 10/07/1986
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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