The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Disposable Coupling Adaptor.
| Device ID | K801261 |
| 510k Number | K801261 |
| Device Name: | DISPOSABLE COUPLING ADAPTOR |
| Classification | Tubing, Pressure And Accessories |
| Applicant | INTEC MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-06-09 |