510(k) K893170
- Device
- VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
- Applicant
- KEELER INSTRUMENTS, INC.
- 510(k) number
- K893170
- Product code
- HJM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-05
- Date received
- 1989-04-25
- Regulation
- 886.1945
- Classification name
- Transilluminator, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VAN ARSDALE
- Address
- 456 Pkwy. Broomall PA US 19008 19008
FDA Registration Numbers#
- 1000391004
- 1315756
- 1423662
- 2918630
- 1000379039
- 2246552
- 2183446
- 3013002167
- 3016798774
- 2025917
- 3009106214
- 2521877
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972506 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Infinitech, Inc. | 1997-10-01 |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | Peregrine Surgical , Ltd. | 1995-06-07 |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Wells Johnson Co. | 1995-03-02 |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Hgm, Inc. | 1994-11-10 |
| K933445 | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | Storz Instrument Co. | 1994-09-23 |
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE | Peregrine Surgical , Ltd. | 1994-09-02 |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | Visitec Co. | 1994-05-17 |
| K913273 | DROLITE(TM) LIGHT SOURCE | Vision Medical, Inc. | 1991-12-04 |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Intl. Ophthalmic Industries Corp. | 1989-10-31 |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Radiation Measurements, Inc. | 1981-12-02 |
| K811108 | RMI TRANSILLUMINATION LIGHT METER #295 | Radiation Measurements, Inc. | 1981-07-01 |
Legacy Summary#
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FDA Review#
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