The following data is part of a premarket notification filed by Tetley Medical Ltd. with the FDA for Tetley Patient Administration Set.
| Device ID | K913416 |
| 510k Number | K913416 |
| Device Name: | TETLEY PATIENT ADMINISTRATION SET |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | TETLEY MEDICAL LTD. C/O DRIAL CONSULTANTS 3216 SHERI DR. Simi Valley, CA 93063 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird TETLEY MEDICAL LTD. C/O DRIAL CONSULTANTS 3216 SHERI DR. Simi Valley, CA 93063 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-31 |
| Decision Date | 1991-10-28 |