The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Tracheostomy Mask.
| Device ID | K913501 |
| 510k Number | K913501 |
| Device Name: | TRACHEOSTOMY MASK |
| Classification | Mask, Oxygen |
| Applicant | B & F MEDICAL PRODUCTS, INC. 1421 N. EXPRESSWAY DR. Toledo, OH 43608 |
| Contact | Jim Spillis |
| Correspondent | Jim Spillis B & F MEDICAL PRODUCTS, INC. 1421 N. EXPRESSWAY DR. Toledo, OH 43608 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1992-01-13 |