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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 K960924
Device Name KOWA HAND-HELD APPLANATION TONOMETER HA-1
Applicant
Kowa Optimed, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact SAMIA N RODRIQUEZ, ESQ.
Correspondent
Kowa Optimed, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact SAMIA N RODRIQUEZ, ESQ.
Regulation Number886.1930
Classification Product Code
HKY  
Date Received03/06/1996
Decision Date 06/04/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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