The following data is part of a premarket notification filed by Iti Medical Technologies, Inc. with the FDA for Midas Touch Bipolar Forceps.
Device ID | K982705 |
510k Number | K982705 |
Device Name: | MIDAS TOUCH BIPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore, CA 94550 |
Contact | Roger Werne |
Correspondent | Roger Werne ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore, CA 94550 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-03 |
Decision Date | 1998-09-08 |
Summary: | summary |