The following data is part of a premarket notification filed by Us Endoscopy with the FDA for Reusable Monopolar Active Cord.
Device ID | K192518 |
510k Number | K192518 |
Device Name: | Reusable Monopolar Active Cord |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | US Endoscopy 5976 Heisley Road Mentor, OH 44060 |
Contact | Gregory Land |
Correspondent | Gregory Land US Endoscopy 5976 Heisley Road Mentor, OH 44060 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-13 |
Decision Date | 2019-10-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995185213 | K192518 | 000 |