The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Neotract Urolift System.
Device ID | K133281 |
510k Number | K133281 |
Device Name: | NEOTRACT UROLIFT SYSTEM |
Classification | Implantable Transprostatic Tissue Retractor System |
Applicant | NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
Contact | Nancy E Isaac |
Correspondent | Nancy E Isaac NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
Product Code | PEW |
CFR Regulation Number | 876.5530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-25 |
Decision Date | 2013-12-20 |
Summary: | summary |