The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Ablator Electrode.
Device ID | K983652 |
510k Number | K983652 |
Device Name: | ABLATOR ELECTRODE |
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 | 1998-10-19 |
Decision Date | 1999-03-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854035600 | K983652 | 000 |
10845854035597 | K983652 | 000 |
20845854035587 | K983652 | 000 |
10845854035573 | K983652 | 000 |
20845854027056 | K983652 | 000 |
20845854027049 | K983652 | 000 |
10845854027059 | K983652 | 000 |
10845854027042 | K983652 | 000 |
20845854029531 | K983652 | 000 |