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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 K873460
Device Name OPHTHALAS DYE OPHTHALMIC LASER
Applicant
BIOPHYSIC MEDICAL, INC.
40 CRANE HILL RD.
SUFFIELD,  CT  06078
Applicant Contact WILLIAM C NEALON
Correspondent
BIOPHYSIC MEDICAL, INC.
40 CRANE HILL RD.
SUFFIELD,  CT  06078
Correspondent Contact WILLIAM C NEALON
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/28/1987
Decision Date 10/29/1987
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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