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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Absorbable, (Scleral Buckling Methods)
510(k) Number K896350
Device Name TITAN AIR SPECTACLE FRAME
Applicant
Acces Intl. Eyewear
444 Bunker Rd.
West Palm Beach,  FL  33405
Applicant Contact STEPHAN LAUDICINO
Correspondent
Acces Intl. Eyewear
444 Bunker Rd.
West Palm Beach,  FL  33405
Correspondent Contact STEPHAN LAUDICINO
Regulation Number886.3300
Classification Product Code
HQJ  
Date Received11/06/1989
Decision Date 12/18/1989
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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