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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 K853890
Device Name OPHTHALMIC LASER PHOTOCOAGULATOR
Applicant
MIRA, INC.
87 RUMFORD AVE.
WALTHAM,  MA  02453 -3846
Applicant Contact MARK W FURLONG
Correspondent
MIRA, INC.
87 RUMFORD AVE.
WALTHAM,  MA  02453 -3846
Correspondent Contact MARK W FURLONG
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/19/1985
Decision Date 11/12/1985
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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