The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Lva System Multi-cap Series Lva51-1/2/3/4/5.
Device ID | K870203 |
510k Number | K870203 |
Device Name: | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 |
Classification | Telescope, Spectacle, Low-vision |
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 | HKK |
CFR Regulation Number | 886.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-20 |
Decision Date | 1987-02-12 |