The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Modified Sterile Disposable Stopcocks.
| Device ID | K781579 |
| 510k Number | K781579 |
| Device Name: | MODIFIED STERILE DISPOSABLE STOPCOCKS |
| 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 | 1978-09-15 |
| Decision Date | 1978-10-05 |