510(k) K023092
- Device
- BD K-4000 MICROKERATOME SYSTEM
- Applicant
- BECTON DICKINSON & CO.
- 510(k) number
- K023092
- Product code
- HMY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-18
- Date received
- 2002-09-18
- Regulation
- 886.4370
- Classification name
- Keratome, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EILEEN T SCHWEIGHARDT
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3010383847
- 3016214537
- 9615659
- 2246552
- 3000264417
Source Documents#
Other 510(k) Records For Product Code HMY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040297 | ONEUSE- PLUS MICROKERATOME | Moria SA | 2004-03-31 |
| K022637 | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME | Becton, Dickinson & CO | 2002-10-16 |
| K022560 | M2 SINGLE USE MICROKERTOME | Moria SA | 2002-09-27 |
| K003594 | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | Moria, Inc. | 2001-03-09 |
| K002191 | CARRIAZO BARRAQUER II MICROKERATOME | Moria, Inc. | 2000-10-12 |
| K992687 | MILLENIUM MICROKERATOME, MODEL IMD-001 | Industrial & Medical Design, Inc. | 1999-09-24 |
| K984537 | KERATOME SYSTEM, MODEL K3000 | Insight Technologies Instruments, LLC | 1999-05-14 |
| K981741 | CARRIAZO BARRAQUER MICROKERATOME | Moria, Inc. | 1998-07-24 |
| K974243 | KERATOME SYSTEM | Insight Technologies Instruments, LLC | 1998-01-20 |
| K902857 | VISI-DRAPE OPHTHALMIC DRAPES | Visitec Co. | 1990-07-31 |
| K781412 | OSCILLATING KNIFE AND ACCESSORIES | Codman & Shurtleff, Inc. | 1978-10-11 |
Legacy Summary#
summary
FDA Review#
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