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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K925254
Device Name AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
Applicant
Allergan Medical Optics
Km 4,2 Rd. 402
Anasco,  PR  00610
Applicant Contact BARBARA A NIKSCH
Correspondent
Allergan Medical Optics
Km 4,2 Rd. 402
Anasco,  PR  00610
Correspondent Contact BARBARA A NIKSCH
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/19/1992
Decision Date 01/07/1993
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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