The following data is part of a premarket notification filed by E. Benson Hood Laboratories, Inc. with the FDA for Laryngeal Stent.
| Device ID | K841347 |
| 510k Number | K841347 |
| Device Name: | LARYNGEAL STENT |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | E. BENSON HOOD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815347023311 | K841347 | 000 |
| 00815347023236 | K841347 | 000 |
| 00815347023243 | K841347 | 000 |
| 00815347023250 | K841347 | 000 |
| 00815347023267 | K841347 | 000 |
| 00815347023274 | K841347 | 000 |
| 00815347023281 | K841347 | 000 |
| 00815347023298 | K841347 | 000 |
| 00815347023304 | K841347 | 000 |
| 00815347023229 | K841347 | 000 |