The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Omnipulse/omnipulse-max.
Device ID | K962632 |
510k Number | K962632 |
Device Name: | OMNIPULSE/OMNIPULSE-MAX |
Classification | Powered Laser Surgical Instrument |
Applicant | TRIMEDYNE, INC. 2801 BARRANCA RD. P.O. BOX 57001 Irvine, CA 92619 -7001 |
Contact | Susan H Gamble |
Correspondent | Susan H 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 | 1996-07-05 |
Decision Date | 1997-01-16 |
Summary: | summary |