510(k) K801381
- Device
- FITE FIXATION TOY FOR OCULAR EXAM
- Applicant
- FITE ENGINEERING CORP.
- 510(k) number
- K801381
- Product code
- HPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-28
- Date received
- 1980-06-11
- Regulation
- 886.1290
- Classification name
- Device, Fixation, Ac-powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1418300
- 2518410
- 1036836
- 9710334
- 3011680766
- 3010300699
- 3005205657
- 3003951061
- 3043041478
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931731 | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY | Storz Instrument Co. | 1994-08-29 |
| K933739 | 360 DEGREE FIXATION LIGHT | Varitronics | 1994-03-14 |
| K873914 | ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) | Richmond Products, Inc. | 1987-12-11 |
| K854383 | KERATOLUX | Carl Zeiss, Inc. | 1985-11-12 |
| K800112 | AMBLYOPIA TRAINER | Life-Tech Instruments, Inc. | 1980-03-10 |
| K781313 | VISION-STIMULATOR, CAM | Clement Clarke, Inc. | 1979-01-26 |
Legacy Summary#
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FDA Review#
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