The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Key-med Fibrescope Disinfection Trolley.
Device ID | K810818 |
510k Number | K810818 |
Device Name: | KEY-MED FIBRESCOPE DISINFECTION TROLLEY |
Classification | Accessories, Cleaning, For Endoscope |
Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FEB |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-24 |
Decision Date | 1981-04-08 |