510(k) K851557
- Device
- ANESTHESIOMETER
- Applicant
- LUNEAU SA
- 510(k) number
- K851557
- Product code
- HJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-30
- Date received
- 1985-04-16
- Regulation
- 886.1040
- Classification name
- Esthesiometer, Ocular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHAMBORD
- Address
- Bp 252 Chartres Cedex FR 28005 28005
FDA Registration Numbers#
- 3023271442
- 3009173773
- 3009420598
- 8040278
- 3042228518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920271 | WEINSTEIN CORNEAL MIRCOAESTHESIOMETER | Connecticut Bioinstruments, Inc. | 1992-04-21 |
Legacy Summary#
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FDA Review#
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