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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 K962931
Device Name SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
Applicant
Smiths Industries Medical Systems, Inc.
15 Kit St.
Keene,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Smiths Industries Medical Systems, Inc.
15 Kit St.
Keene,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
GJE  
Date Received07/29/1996
Decision Date 10/21/1996
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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