The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Tenosnare.
Device ID | K970562 |
510k Number | K970562 |
Device Name: | TENOSNARE |
Classification | Arthroscope |
Applicant | LUXTEC CORP. 45 PONTIAC RD. Newton, MA 02168 |
Contact | Joseph Ress |
Correspondent | Joseph Ress LUXTEC CORP. 45 PONTIAC RD. Newton, MA 02168 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-13 |
Decision Date | 1997-05-14 |