The following data is part of a premarket notification filed by Medical Innovations International, Inc. with the FDA for Barton-mayo Tracheostoma Button.
| Device ID | K901377 |
| 510k Number | K901377 |
| Device Name: | BARTON-MAYO TRACHEOSTOMA BUTTON |
| Classification | Tube, Laryngectomy |
| Applicant | MEDICAL INNOVATIONS INTERNATIONAL, INC. 3105 N.W. 22ND ST. Rochester, MN 55901 |
| Contact | Todd J Hein |
| Correspondent | Todd J Hein MEDICAL INNOVATIONS INTERNATIONAL, INC. 3105 N.W. 22ND ST. Rochester, MN 55901 |
| Product Code | KAC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-22 |
| Decision Date | 1990-06-14 |