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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 K032967
Device Name PASCAL DYNAMIC CONTOUR TONOMETER
Applicant
Smt Swiss Microtechnology AG
13 Red Fox Lane
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Smt Swiss Microtechnology AG
13 Red Fox Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/23/2003
Decision Date 11/14/2003
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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