The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Cts Relief Kit.
Device ID | K941651 |
510k Number | K941651 |
Device Name: | CTS RELIEF KIT |
Classification | Arthroscope |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
Contact | Carol A Weideman |
Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-05 |
Decision Date | 1995-01-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CTS RELIEF KIT 74236006 1851199 Live/Registered |
CONMED CORPORATION 1992-01-08 |