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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 K953199
Device Name METRO 55G TORIC & SPHERICAL
Applicant
Metrosoft, Inc.
235 N. Talbot Ct.
Rosewell,  GA  30076
Applicant Contact WALLY STIRLING
Correspondent
Metrosoft, Inc.
235 N. Talbot Ct.
Rosewell,  GA  30076
Correspondent Contact WALLY STIRLING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/10/1995
Decision Date 12/11/1995
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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