The following data is part of a premarket notification filed by Pennine Medical Ltd. with the FDA for Pennine Oxygen Link Tubing.
| Device ID | K852081 |
| 510k Number | K852081 |
| Device Name: | PENNINE OXYGEN LINK TUBING |
| Classification | Tubing, Pressure And Accessories |
| Applicant | PENNINE MEDICAL LTD. P.O. BOX 648 Stoughton, MA 02072 |
| Contact | David S Locke |
| Correspondent | David S Locke PENNINE MEDICAL LTD. P.O. BOX 648 Stoughton, MA 02072 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-06-14 |