The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Resolution Clip.
Device ID | K142973 |
510k Number | K142973 |
Device Name: | Resolution Clip |
Classification | Hemostatic Metal Clip For The Gi Tract |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
Contact | Elena Nieves |
Correspondent | Elena Nieves Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
Product Code | PKL |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-14 |
Decision Date | 2014-12-01 |
Summary: | summary |