The following data is part of a premarket notification filed by Tenex Health, Inc. with the FDA for Tenex Health Tx System With The Txp Microtip.
Device ID | K181367 |
510k Number | K181367 |
Device Name: | Tenex Health TX System With The TXP MicroTip |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Tenex Health, Inc. 26902 Vista Terrace Lake Forest,, CA 92630 |
Contact | David Vancelette |
Correspondent | David Vancelette Tenex Health, Inc. 26902 Vista Terrace Lake Forest,, CA 92630 |
Product Code | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-23 |
Decision Date | 2018-08-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857156006123 | K181367 | 000 |
00857156006338 | K181367 | 000 |
00857156006109 | K181367 | 000 |
00857156006079 | K181367 | 000 |
00857156006406 | K181367 | 000 |