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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 K032769
Device Name EYESOPEN TONOMETER
Applicant
EYE-DEAS, LLC
39 SANDRINGHAM RD.
ROCHESTER,  NY  14610
Applicant Contact STEVEN E FELDON
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ERIN SPARNON
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/08/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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