The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Laser-flex(tm) Tracheal Tube (cuffed).
| Device ID | K873461 |
| 510k Number | K873461 |
| Device Name: | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809 |
| Contact | E Wiegert,phd |
| Correspondent | E Wiegert,phd MALLINCKRODT CRITICAL CARE HOOK RD. Argyle, NY 12809 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-28 |
| Decision Date | 1987-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40884522002067 | K873461 | 000 |
| 40884522002050 | K873461 | 000 |
| 40884522002043 | K873461 | 000 |
| 40884522002036 | K873461 | 000 |
| 20884522002063 | K873461 | 000 |
| 20884522002056 | K873461 | 000 |
| 20884522002049 | K873461 | 000 |
| 20884522002032 | K873461 | 000 |