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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K033146
Device Name TONO-PEN TONOMETER TIP COVER
Applicant
Tra & Accessories
449 W. Allen Ave. Suite 107
San Dimas,  CA  91773
Applicant Contact RICHARD MASTROLEO
Correspondent
Tra & Accessories
449 W. Allen Ave. Suite 107
San Dimas,  CA  91773
Correspondent Contact RICHARD MASTROLEO
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/30/2003
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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