The following data is part of a premarket notification filed by Woodlyn, Inc. with the FDA for Woodlyn Classic Slit Lamp Hssl-cl.
Device ID | K841761 |
510k Number | K841761 |
Device Name: | WOODLYN CLASSIC SLIT LAMP HSSL-CL |
Classification | Ophthalmoscope, Ac-powered |
Applicant | WOODLYN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HLI |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-27 |
Decision Date | 1984-08-07 |