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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 K022723
Device Name MASTEL 1 FOLDER IMPLANTATION SYSTEM
Applicant
Mastel Precision, Inc.
53 Barcelona
Irvine,  CA  92614
Applicant Contact MAUREEN WEINER
Correspondent
Mastel Precision, Inc.
53 Barcelona
Irvine,  CA  92614
Correspondent Contact MAUREEN WEINER
Regulation Number886.4300
Classification Product Code
KYB  
Date Received08/16/2002
Decision Date 12/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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