The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Shaver Ablator.
Device ID | K002088 |
510k Number | K002088 |
Device Name: | SHAVER ABLATOR |
Classification | Arthroscope |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Laura D Seneff |
Correspondent | Laura D 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 | 2000-07-11 |
Decision Date | 2001-03-06 |