The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Radiopaque Laryngeal Keel.
| Device ID | K962693 |
| 510k Number | K962693 |
| Device Name: | MONTGOMERY RADIOPAQUE LARYNGEAL KEEL |
| Classification | Prosthesis, Larynx (stents And Keels) |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Product Code | FWN |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-11 |
| Decision Date | 1996-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES323060R0 | K962693 | 000 |
| EBES323050R0 | K962693 | 000 |
| EBES323040R0 | K962693 | 000 |
| 34063107100544 | K962693 | 000 |
| 34063107100520 | K962693 | 000 |
| 34063107100506 | K962693 | 000 |