The following data is part of a premarket notification filed by King Tool, Inc. with the FDA for Eye See Instrument.
Device ID | K905237 |
510k Number | K905237 |
Device Name: | EYE SEE INSTRUMENT |
Classification | Magnet, Permanent |
Applicant | KING TOOL, INC. 5350 LOVE LN. Bozeman, MT 59718 -9408 |
Contact | Clarence A Emerson |
Correspondent | Clarence A Emerson KING TOOL, INC. 5350 LOVE LN. Bozeman, MT 59718 -9408 |
Product Code | HPN |
CFR Regulation Number | 886.4445 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-16 |
Decision Date | 1991-02-14 |