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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 K890509
Device Name INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
Applicant
Biophysic Medical, Inc.
2440 Estand Way
Pleasant Hill,  CA  94523
Applicant Contact DOUGLAS DONALDSON
Correspondent
Biophysic Medical, Inc.
2440 Estand Way
Pleasant Hill,  CA  94523
Correspondent Contact DOUGLAS DONALDSON
Regulation Number886.4390
Classification Product Code
HQF  
Date Received02/01/1989
Decision Date 03/24/1989
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
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