The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Rhinocell Nasal Packings.
| Device ID | K972459 |
| 510k Number | K972459 |
| Device Name: | RHINOCELL NASAL PACKINGS |
| Classification | Balloon, Epistaxis |
| 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 | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBESTP8010301 | K972459 | 000 |
| EBESEP5515251 | K972459 | 000 |
| EBESNP4515201 | K972459 | 000 |
| EBESNP8015201 | K972459 | 000 |
| EBESNP801520A1 | K972459 | 000 |
| EBESNP8015301 | K972459 | 000 |
| EBESNP801530A1 | K972459 | 000 |
| EBESSP3506120 | K972459 | 000 |
| EBESSP3509120 | K972459 | 000 |
| EBESTP4510201 | K972459 | 000 |
| EBESTP8010201 | K972459 | 000 |
| EBESEP10015251 | K972459 | 000 |