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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name folders and injectors, intraocular lens (iol)
510(k) Number K123888
Device Name Z CARTRIDGE IOL DELIVERY SYSTEM
Applicant
AAREN SCIENTIFIC, INC
4290 E. BRICKELL ST. BLDG A
ONTARIO,  CA  91761
Applicant Contact ROBERT K SHEEHAN
Correspondent
AAREN SCIENTIFIC, INC
4290 E. BRICKELL ST. BLDG A
ONTARIO,  CA  91761
Correspondent Contact ROBERT K SHEEHAN
Regulation Number886.4300
Classification Product Code
MSS  
Date Received12/18/2012
Decision Date 04/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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