The following data is part of a premarket notification filed by Owens-brigam Medical Co. with the FDA for Brigam Medical Disposable Anesthesia/respiratory Face Mask.
| Device ID | K952689 |
| 510k Number | K952689 |
| Device Name: | BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | OWENS-BRIGAM MEDICAL CO. 65 HANES RD. Newland, NC 28657 |
| Contact | Bill Brooks |
| Correspondent | Bill Brooks OWENS-BRIGAM MEDICAL CO. 65 HANES RD. Newland, NC 28657 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-07-11 |