The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Anchor Bag-alone Tissue Retrieval System By Conmed.
Device ID | K183600 |
510k Number | K183600 |
Device Name: | Anchor Bag-Alone Tissue Retrieval System By ConMed |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
Contact | Jessica Swafford |
Correspondent | Jessica Swafford 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 | 2018-12-26 |
Decision Date | 2019-03-13 |