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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K943948
Device Name PROTECTIVE SHORTS
Applicant
Y. Daneshvar, M.D.
33433 W. Six Mile Rd.
Livonia,  MI  48152
Applicant Contact Y. DANESHAVAR
Correspondent
Y. Daneshvar, M.D.
33433 W. Six Mile Rd.
Livonia,  MI  48152
Correspondent Contact Y. DANESHAVAR
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/18/1994
Decision Date 06/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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