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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Ophthalmic
510(k) Number K860744
Device Name OPTHALMIC SURGICAL INSTRUMENTS
Applicant
Tridak Division of Indicon, Inc.
One Blue Hill Plz.
Suite 815
Pearl River,  NY  10965
Applicant Contact CORINNE M AMBROSINO
Correspondent
Tridak Division of Indicon, Inc.
One Blue Hill Plz.
Suite 815
Pearl River,  NY  10965
Correspondent Contact CORINNE M AMBROSINO
Regulation Number886.4350
Classification Product Code
HMX  
Date Received02/27/1986
Decision Date 03/31/1986
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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