The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Reinforced Tracheostomy Tube Set(tentat).
| Device ID | K810321 |
| 510k Number | K810321 |
| Device Name: | REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-06 |
| Decision Date | 1981-03-04 |