The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Zone Specific Aim.
Device ID | K220186 |
510k Number | K220186 |
Device Name: | Zone Specific AIM |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | CONMED Corporation 525 French Road Utica, NY 13502 |
Contact | Orjada Dervishleri |
Correspondent | Orjada Dervishleri ConMed Corporation 11311 Concept Boulevard Largo, FL 33773 -4908 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-24 |
Decision Date | 2022-05-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854649906 | K220186 | 000 |
20845854649890 | K220186 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZONE SPECIFIC AIM 90704280 not registered Live/Pending |
Conmed Corporation 2021-05-11 |