The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Mini-trach Kit.
| Device ID | K862167 |
| 510k Number | K862167 |
| Device Name: | MINI-TRACH KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PORTEX, INC. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | E. G Grove |
| Correspondent | E. G Grove PORTEX, INC. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-08-06 |