The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Stopcock.
| Device ID | K780271 |
| 510k Number | K780271 |
| Device Name: | COBE STOPCOCK |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-17 |
| Decision Date | 1978-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333201895 | K780271 | 000 |
| 20886333201321 | K780271 | 000 |
| 20886333201338 | K780271 | 000 |
| 20886333201352 | K780271 | 000 |
| 20886333201376 | K780271 | 000 |
| 20886333201383 | K780271 | 000 |
| 20886333201444 | K780271 | 000 |
| 20886333201468 | K780271 | 000 |
| 20886333201482 | K780271 | 000 |
| 20886333201499 | K780271 | 000 |
| 20886333201505 | K780271 | 000 |
| 20886333201888 | K780271 | 000 |
| 20886333201314 | K780271 | 000 |