The following data is part of a premarket notification filed by Pharma-plast Usa, Inc. with the FDA for Multiple Pharma-plast Tracheal Tube.
| Device ID | K871263 |
| 510k Number | K871263 |
| Device Name: | MULTIPLE PHARMA-PLAST TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | PHARMA-PLAST USA, INC. 1801 MCGILL COLLEGE AVE. SUITE 1470, MONTREAL Canada H3a 2n4, CA |
| Contact | Douglas M Bennett |
| Correspondent | Douglas M Bennett PHARMA-PLAST USA, INC. 1801 MCGILL COLLEGE AVE. SUITE 1470, MONTREAL Canada H3a 2n4, CA |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-06-15 |