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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K883719
Device Name INTERCONN. OF OPHTHALAS & NANOLAS LASER 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
LQJ  
Date Received08/31/1988
Decision Date 10/18/1988
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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