The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Lateralase, Modified.
Device ID | K944204 |
510k Number | K944204 |
Device Name: | LATERALASE, MODIFIED |
Classification | Powered Laser Surgical Instrument |
Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
Contact | Susan Gamble |
Correspondent | Susan Gamble TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-12 |
Decision Date | 1994-11-28 |