The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Core E3 Suction/irrigator.
Device ID | K202303 |
510k Number | K202303 |
Device Name: | CORE E3 Suction/irrigator |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
Contact | Tina Mornak |
Correspondent | Tina Mornak ConMed Corporation 525 French Road Utica, NY 13502 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-14 |
Decision Date | 2021-02-19 |