The following data is part of a premarket notification filed by Current Technologies, Inc. with the FDA for Prefilled Arterial Blood Sampling Syring.
| Device ID | K810816 |
| 510k Number | K810816 |
| Device Name: | PREFILLED ARTERIAL BLOOD SAMPLING SYRING |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | CURRENT TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-07 |