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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 K832939
Device Name I-GLIDE IOL IMPLANTATION AID
Applicant
I For M, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
I For M, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.4300
Classification Product Code
KYB  
Date Received08/30/1983
Decision Date 10/04/1983
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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