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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 K132549
Device Name ACCUTIP COVER
Applicant
ACCUTOME, INC.
3222 PHOENIXVILLE PIKE
MALVERN,  PA  19355
Applicant Contact ADAM PICKHOLTZ
Correspondent
ACCUTOME, INC.
3222 PHOENIXVILLE PIKE
MALVERN,  PA  19355
Correspondent Contact ADAM PICKHOLTZ
Regulation Number886.1930
Classification Product Code
HKY  
Date Received08/14/2013
Decision Date 04/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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