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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K961606
Device Name METRO FOCAL ASPHERIC (POLYMACON)
Applicant
Metro Optics of Austin, Inc.
235 N. Talbot Ct.
Rosewell,  GA  30076
Applicant Contact WALLY STIRLING
Correspondent
Metro Optics of Austin, Inc.
235 N. Talbot Ct.
Rosewell,  GA  30076
Correspondent Contact WALLY STIRLING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/25/1996
Decision Date 11/20/1996
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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