The following data is part of a premarket notification filed by Andover Medical, Inc. with the FDA for Unilateral Oxygen Delivery System (ulods).
| Device ID | K860535 |
| 510k Number | K860535 |
| Device Name: | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) |
| Classification | Cannula, Nasal, Oxygen |
| Applicant | ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Contact | John F Cavallaro |
| Correspondent | John F Cavallaro ANDOVER MEDICAL, INC. 23 BALLARD WAY Lawrence, MA 01843 |
| Product Code | CAT |
| CFR Regulation Number | 868.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-12 |
| Decision Date | 1986-04-01 |