The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Urolift System Procedure Kit Sterilization Tray.
Device ID | K192781 |
510k Number | K192781 |
Device Name: | UroLift System Procedure Kit Sterilization Tray |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | NeoTract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
Contact | Brian Gall |
Correspondent | Brian Gall NeoTract, Inc. 4155 Hopyard Rd. Pleasanton, CA 94588 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-30 |
Decision Date | 2020-04-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00814932020056 | K192781 | 000 |