The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Resolution Hemostasis Clipping Device.
| Device ID | K040148 |
| 510k Number | K040148 |
| Device Name: | RESOLUTION HEMOSTASIS CLIPPING DEVICE |
| Classification | Clip, Hemostatic |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | James D Mcmahon |
| Correspondent | James D Mcmahon BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | MCH |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-23 |
| Decision Date | 2004-04-22 |
| Summary: | summary |