The following data is part of a premarket notification filed by Keithley Development Co. with the FDA for Keithley Clamp.
Device ID | K792256 |
510k Number | K792256 |
Device Name: | KEITHLEY CLAMP |
Classification | Tourniquet, Gastro-urology |
Applicant | KEITHLEY DEVELOPMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EYR |
CFR Regulation Number | 878.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-09 |
Decision Date | 1979-12-06 |