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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryophthalmic
510(k) Number K923629
Device Name OPHTHALMIC TRICHIASIS PROBE
Applicant
MIRA, INC.
87 RUMFORD AVE.
WALTHAM,  MA  02453 -3846
Applicant Contact ROGER O'BRIEN
Correspondent
MIRA, INC.
87 RUMFORD AVE.
WALTHAM,  MA  02453 -3846
Correspondent Contact ROGER O'BRIEN
Regulation Number886.4170
Classification Product Code
HPS  
Date Received07/21/1992
Decision Date 10/19/1992
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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