The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Pro-vent, Line Draw, Pulsator.
Device ID | K952516 |
510k Number | K952516 |
Device Name: | PRO-VENT, LINE DRAW, PULSATOR |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
Contact | Timothy J Talcott |
Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-31 |
Decision Date | 1995-07-14 |