The following data is part of a premarket notification filed by Tenex Health, Inc. with the FDA for Tenex Health Tx System.
Device ID | K153299 |
510k Number | K153299 |
Device Name: | Tenex Health TX System |
Classification | Instrument, Ultrasonic Surgical |
Applicant | TENEX HEALTH, INC. 26902 VISTA TERRACE Lake Forest, CA 92630 |
Contact | Gloria Pendergrass |
Correspondent | Gloria Pendergrass 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 | 2015-11-13 |
Decision Date | 2016-03-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857156006185 | K153299 | 000 |
00857156006161 | K153299 | 000 |
00857156006147 | K153299 | 000 |