The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Apex Tubing Set.
Device ID | K954440 |
510k Number | K954440 |
Device Name: | APEX TUBING SET |
Classification | Arthroscope |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Carol A Weideman |
Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-25 |
Decision Date | 1995-11-02 |