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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 K962000
Device Name FLEXLENS(METHAFILCON A)
Applicant
Flexlens, Inc.
S. E. Regulatory Asso., Inc.
235 N. Talbot Court
Roswell,  GA  30076 -2480
Applicant Contact WALLY STIRLING
Correspondent
Flexlens, Inc.
S. E. Regulatory Asso., Inc.
235 N. Talbot Court
Roswell,  GA  30076 -2480
Correspondent Contact WALLY STIRLING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/22/1996
Decision Date 10/01/1996
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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