510(k) K791923
- Device
- Scleral Powder
- Applicant
- OCULARISTS LTD.
- 510(k) number
- K791923
- Product code
- HQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-10
- Date received
- 1979-09-26
- Regulation
- 886.3200
- Classification name
- Eye, Artificial, Non-Custom
- 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#
- 2183958
- 3006342671
- 8030607
- 8040382
- 2935668
- 3006419344
- 3006142527
- 1932994
- 3004028897
- 3005690771
- 3003951061
- 9610790
- 1000220575
- 3014865
- 9612297
- 2183831
- 1045379
- 8040381
- 2183957
- 3007096749
- 2183955
- 2519029
- 1824736
- 3004475955
- 1646945
- 1836161
- 3005147029
- 3042228518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952538 | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | 1995-06-26 |
| K945270 | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | 1995-05-30 |
| K946226 | CUSTOM OCULAR PROSTHESIS | Frank Tanaka, Ocularist, Inc. | 1995-03-22 |
| K923167 | THE NISSEL ARTIFICIAL EYE | Nissel , Ltd. | 1992-09-02 |
| K904962 | EYE ARTIFICIAL CUSTOM | Midwest Eye Laboratories, Inc. | 1991-08-30 |