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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, ac-powered
510(k) Number K013259
Device Name PORTABLE NON-CONTACT TONOMETER, MODEL PT100
Applicant
LEICA MICROSYSTEMS, INC. O.I.D.
3374 WALDEN AVE.
DEPEW,  NY  14043
Applicant Contact FRANK J DREXELIUS
Correspondent
LEICA MICROSYSTEMS, INC. O.I.D.
3374 WALDEN AVE.
DEPEW,  NY  14043
Correspondent Contact FRANK J DREXELIUS
Regulation Number886.1930
Classification Product Code
HKX  
Date Received10/01/2001
Decision Date 02/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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