The following data is part of a premarket notification filed by Premier Medical with the FDA for Modified Decannulation Stopper.
| Device ID | K894050 |
| 510k Number | K894050 |
| Device Name: | MODIFIED DECANNULATION STOPPER |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PREMIER MEDICAL 10090 SANDMEYER LN. Philadelphia, PA 19116 -3502 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER MEDICAL 10090 SANDMEYER LN. Philadelphia, PA 19116 -3502 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-08-01 |