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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 K151491
Device Name Falck Medical Multifunction Tonometer, FAT1
Applicant
FALCK MEDICAL, INC
35 WASHINGTON STREET
MYSTIC,  CT  06355
Applicant Contact FRANCIS FALCK
Correspondent
FALCK MEDICAL, INC
35 WASHINGTON STREET
MYSTIC,  CT  06355
Correspondent Contact FRANCIS FALCK
Regulation Number886.1930
Classification Product Code
HKY  
Subsequent Product Codes
HPK   NJJ  
Date Received06/03/2015
Decision Date 01/15/2016
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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