The following data is part of a premarket notification filed by Steris Corporation with the FDA for Avulsion Forceps.
Device ID | K183428 |
510k Number | K183428 |
Device Name: | Avulsion Forceps |
Classification | Forceps, Biopsy, Electric |
Applicant | STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
Contact | Eileen Mccafferty |
Correspondent | Eileen Mccafferty STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 |
Product Code | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-11 |
Decision Date | 2019-04-16 |