The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Disposable Elbow Adaptor.
| Device ID | K810620 |
| 510k Number | K810620 |
| Device Name: | DISPOSABLE ELBOW ADAPTOR |
| Classification | Connector, Airway (extension) |
| Applicant | INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015 |
| Contact | J.w. Brown |
| Correspondent | J.w. Brown INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-09 |
| Decision Date | 1981-03-20 |