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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 K071755
Device Name FALCK APPLANATION TONOMETER (FAT2)
Applicant
Falck Medical, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
Falck Medical, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.1930
Classification Product Code
HKY  
Subsequent Product Codes
HPK   NJJ  
Date Received06/28/2007
Decision Date 06/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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