Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K945777
Device Name PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
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 Received11/25/1994
Decision Date 12/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-