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 |