The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd-3000 Microkeratome System, Model K-3000 Microkeratome.
Device ID | K022637 |
510k Number | K022637 |
Device Name: | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME |
Classification | Keratome, Battery-powered |
Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Contact | Eileen T Schweighardt |
Correspondent | Eileen T Schweighardt BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
Product Code | HMY |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-08 |
Decision Date | 2002-10-16 |
Summary: | summary |