510(k) K842410
- Device
- AMER. EDWARDS LAB FLEXISCOPE
- Applicant
- AMERICAN EDWARDS LABORATORIES
- 510(k) number
- K842410
- Product code
- HRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-05
- Date received
- 1984-06-19
- Regulation
- 886.4855
- Classification name
- Table, Instrument, Manual, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD J EHMSEN
- Address
- P.O. Box 11150 17221 Red Hill Ave.(Irvine) Santa Ana CA US 92711 92711
FDA Registration Numbers#
- 3006550126
- 2437956
- 3010675798
- 3007886583
- 3020410096
- 3011898560
- 3004438145
- 3007817024
- 1054811
- 3003553186
- 3013846070
- 3003951061
- 3013398127
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HRK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760697 | EVANS ARM AND HAND REST | Alcon Laboratories | 1976-11-02 |
Legacy Summary#
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FDA Review#
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