The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Saf-t Closed Blood Collection System With Saf-holder Device, Model 99200, Saf-t Closed Blood Collection System With.
| Device ID | K072783 |
| 510k Number | K072783 |
| Device Name: | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brian Farias |
| Correspondent | Brian Farias SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. 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 | 2007-10-01 |
| Decision Date | 2007-11-30 |
| Summary: | summary |