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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K081229
Device Name SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
Applicant
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact BRIAN FARIAS
Correspondent
Smiths Medical Asd, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact BRIAN FARIAS
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/30/2008
Decision Date 07/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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