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 |