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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, syringe needle
510(k) Number K060141
Device Name DAI-R
Applicant
SHL MEDICAL, USA
23 VREELAND RD.,
SUITE 104
FLORHAM PARK,  NJ  07932
Applicant Contact LUCIO GIAMBATTISTA
Correspondent
SHL MEDICAL, USA
23 VREELAND RD.,
SUITE 104
FLORHAM PARK,  NJ  07932
Correspondent Contact LUCIO GIAMBATTISTA
Regulation Number880.6920
Classification Product Code
KZH  
Date Received01/19/2006
Decision Date 06/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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