The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Epi-stop Epistaxis Catheter.
| Device ID | K972077 |
| 510k Number | K972077 |
| Device Name: | EPI-STOP EPISTAXIS CATHETER |
| 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 | 1997-06-03 |
| Decision Date | 1997-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES60401P0 | K972077 | 000 |
| EBES604010 | K972077 | 000 |