The following data is part of a premarket notification filed by Mallinckrodt Medical Tpi, Inc. with the FDA for Ssv Phonate(tm) Shiley Speaking Valve.
| Device ID | K945406 |
| 510k Number | K945406 |
| Device Name: | SSV PHONATE(TM) SHILEY SPEAKING VALVE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | MALLINCKRODT MEDICAL TPI, INC. 1595 DEERE AVE. P.O. BOX 19614 Irvine, CA 92714 |
| Contact | Robert F Ingham |
| Correspondent | Robert F Ingham MALLINCKRODT MEDICAL TPI, INC. 1595 DEERE AVE. P.O. BOX 19614 Irvine, CA 92714 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1995-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60884522007721 | K945406 | 000 |
| 50884522005362 | K945406 | 000 |
| 20884521751351 | K945406 | 000 |