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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 K952516
Device Name PRO-VENT, LINE DRAW, PULSATOR
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  
Date Received05/31/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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