The following data is part of a premarket notification filed by Premier Dental with the FDA for Premier Decannulation Stopper.
| Device ID | K884015 |
| 510k Number | K884015 |
| Device Name: | PREMIER DECANNULATION STOPPER |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PREMIER DENTAL ROMANO DR. P.O. BOX 111 Norristown, PA 19404 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER DENTAL ROMANO DR. P.O. BOX 111 Norristown, PA 19404 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-22 |
| Decision Date | 1988-11-03 |