The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Laryngectomy Tube.
| Device ID | K873992 |
| 510k Number | K873992 |
| Device Name: | LARYNGECTOMY TUBE |
| Classification | Tube, Laryngectomy |
| Applicant | PORTEX, INC. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Edwin G Grove |
| Correspondent | Edwin G Grove PORTEX, INC. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | KAC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-01 |
| Decision Date | 1988-03-24 |