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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K930320
Device Name AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
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 Number886.4300
Classification Product Code
KYB  
Date Received01/22/1993
Decision Date 04/07/1994
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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