The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Dic Tracheostomy Tube And Portex Blue Line.
Device ID | K934465 |
510k Number | K934465 |
Device Name: | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
Contact | Timothy J Talcott |
Correspondent | Timothy J Talcott SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene, NH 03431 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-13 |
Decision Date | 1994-01-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10351688036933 | K934465 | 000 |
10351688000231 | K934465 | 000 |
10351688000644 | K934465 | 000 |
10351688001481 | K934465 | 000 |
10351688006677 | K934465 | 000 |
10351688009265 | K934465 | 000 |
10351688010339 | K934465 | 000 |
10351688017772 | K934465 | 000 |
10351688021007 | K934465 | 000 |
10351688022066 | K934465 | 000 |
10351688023544 | K934465 | 000 |
10351688024923 | K934465 | 000 |
10351688027900 | K934465 | 000 |
10351688033161 | K934465 | 000 |
10351688036117 | K934465 | 000 |
10351688018243 | K934465 | 000 |