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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 K881494
Device Name FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
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 Received04/08/1988
Decision Date 08/30/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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