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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name knife, ophthalmic
510(k) Number K922378
Device Name OPHTHALMIC KNIFE
Applicant
MICROPTICS DEVELOPMENT LABORATORY
3855 BIRCH ST.
NEWPORT BEACH,  CA  92660
Applicant Contact MARK STEEN
Correspondent
MICROPTICS DEVELOPMENT LABORATORY
3855 BIRCH ST.
NEWPORT BEACH,  CA  92660
Correspondent Contact MARK STEEN
Regulation Number886.4350
Classification Product Code
HNN  
Date Received05/20/1992
Decision Date 12/10/1992
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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