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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Ophthalmic
510(k) Number K864183
Device Name OPHTHALMIC SURGICAL INSTRUMENTS
Applicant
Techno Ophthalmics Intl.
15a Marconi St.
Irvine,  CA  92718
Applicant Contact S. K MCGARVEY
Correspondent
Techno Ophthalmics Intl.
15a Marconi St.
Irvine,  CA  92718
Correspondent Contact S. K MCGARVEY
Regulation Number886.4350
Classification Product Code
HNR  
Date Received10/27/1986
Decision Date 11/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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