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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 K942302
Device Name ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS
Applicant
Preferred Optics, Inc.
122 Cherry St.
Marietta,  GA  30060
Applicant Contact PENNY NORTHCUTT
Correspondent
Preferred Optics, Inc.
122 Cherry St.
Marietta,  GA  30060
Correspondent Contact PENNY NORTHCUTT
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/12/1994
Decision Date 08/05/1994
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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