510(k) K861747
- Device
- KEELER FIBEROPTIC HEADLAMP
- Applicant
- KEELER INSTRUMENTS, INC.
- 510(k) number
- K861747
- Product code
- HPQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-08-21
- Date received
- 1986-05-06
- Regulation
- 886.4335
- Classification name
- Headlamp, Operating, 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#
- 3021839632
- 3011137372
- 2132111
- 3010041511
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952289 | WELCH ALLYN FIBER OPTIC HEADLIGNT | Welch Allyn, Inc. | 1995-07-14 |
| K951337 | FIBER HEAD LIGHT FH-300 | Neitz Instruments Company, Ltd. | 1995-06-08 |
| K861746 | KEELER DUAL LIGHTSOURCE | Keeler Instruments, Inc. | 1986-08-21 |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Kelleher Corp. | 1982-11-10 |
Legacy Summary#
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FDA Review#
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