The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for E9000 System.
Device ID | K990524 |
510k Number | K990524 |
Device Name: | E9000 SYSTEM |
Classification | Arthroscope |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Laura Seneff |
Correspondent | Laura Seneff 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 | 1999-02-19 |
Decision Date | 1999-07-15 |
Summary: | summary |