The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Konan Specular Microscope Sp3300.
Device ID | K900111 |
510k Number | K900111 |
Device Name: | KEELER KONAN SPECULAR MICROSCOPE SP3300 |
Classification | Ophthalmoscope, Ac-powered |
Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Contact | Van Arsdale |
Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
Product Code | HLI |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-09 |
Decision Date | 1990-03-23 |