The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Bivalve Nasal Splint.
| Device ID | K972096 |
| 510k Number | K972096 |
| Device Name: | BIVALVE NASAL SPLINT |
| Classification | Splint, Intranasal Septal |
| 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 | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES603040 | K972096 | 000 |
| EBES603030 | K972096 | 000 |
| EBES603020 | K972096 | 000 |
| EBES603010 | K972096 | 000 |
| 34063107102326 | K972096 | 000 |
| 34063107102319 | K972096 | 000 |
| 34063107102302 | K972096 | 000 |
| 34063107102296 | K972096 | 000 |