The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Laryngoscope Blades/handles & Lamps.
Device ID | K833055 |
510k Number | K833055 |
Device Name: | LARYNGOSCOPE BLADES/HANDLES & LAMPS |
Classification | Laryngoscope, Rigid |
Applicant | MEDOVATIONS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-07 |
Decision Date | 1983-11-14 |