The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Multi-stage Snare.
Device ID | K133513 |
510k Number | K133513 |
Device Name: | MULTI-STAGE SNARE |
Classification | Snare, Flexible |
Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
Contact | Carroll Martin |
Correspondent | Carroll Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-12 |
Decision Date | 2013-12-20 |