The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Fistula Needle (#11-265).
| Device ID | K760665 |
| 510k Number | K760665 |
| Device Name: | FISTULA NEEDLE (#11-265) |
| 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 | 1976-09-17 |
| Decision Date | 1976-10-21 |