The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Hotip Hemostatic Probe.
Device ID | K843628 |
510k Number | K843628 |
Device Name: | HOTIP HEMOSTATIC PROBE |
Classification | Laser For Gastro-urology Use |
Applicant | TRIMEDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LNK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-14 |
Decision Date | 1985-11-12 |