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 |