The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Stopcock, One Way.
| Device ID | K770383 |
| 510k Number | K770383 |
| Device Name: | STOPCOCK, ONE WAY |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-02-28 |
| Decision Date | 1977-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886333201433 | K770383 | 000 |
| 20886333201420 | K770383 | 000 |
| 20886333201413 | K770383 | 000 |