The following data is part of a premarket notification filed by Pennine Medical Ltd. with the FDA for Pennine Derby Yankauer.
| Device ID | K852079 |
| 510k Number | K852079 |
| Device Name: | PENNINE DERBY YANKAUER |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-06-03 |