The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Tracheolife.
| Device ID | K941535 |
| 510k Number | K941535 |
| Device Name: | TRACHEOLIFE |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Contact | Frank Steciuk |
| Correspondent | Frank Steciuk MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-30 |
| Decision Date | 1994-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884522032534 | K941535 | 000 |