510(k) K022186
- Device
- SCLERAL PLUGS, 19 AND 20 GAUGE
- Applicant
- MICROVISION, INC.
- 510(k) number
- K022186
- Product code
- LXP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-26
- Date received
- 2002-07-05
- Regulation
- 886.4155
- Classification name
- Plug, Scleral
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEONARD KASTRILEVICH
- Address
- 34 Folly Mill Rd. Suite 200 P.O. Box 1651 Seabrook NH US 03874 03874
FDA Registration Numbers#
- 3029973819
- 3008692839
- 1928237
Source Documents#
Other 510(k) Records For Product Code LXP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990872 | SCLERAL PLUGS, 19 AND 20 GAUGE | Ophthalmic Consultants, Inc. | 1999-07-13 |
| K945114 | VISITEC SCLERAL PLUG | Visitec Co. | 1995-02-23 |
| K925671 | DISPOSABLE SCLERAL PLUGS | O.R. Specialties, Inc. | 1993-08-02 |
| K880952 | PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS | Advanced Surgical Products, Inc. | 1988-05-13 |
| K880953 | ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG | Advanced Surgical Products, Inc. | 1988-05-13 |
| K871604 | MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS | Advanced Surgical Products, Inc. | 1987-06-12 |
| K854507 | STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS | Storz Instrument Co. | 1986-02-07 |
| K840693 | DISPOSABLE SCLERAL GLOBE PLUG | Innovative Surgical Products, Inc. | 1984-05-22 |
| K831193 | SCLERAL PLUG | Medical Instrument Development Laboratories, Inc. | 1983-06-30 |
Legacy Summary#
summary
FDA Review#
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