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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 K981035
Device Name PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
Applicant
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/19/1998
Decision Date 04/21/1998
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
Recalls CDRH Recalls
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