510(k) K851811
- Device
- SLIT CAMERA MODEL 07-624
- Applicant
- VICTOREEN, INC.
- 510(k) number
- K851811
- Product code
- IXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-28
- Date received
- 1985-04-26
- Regulation
- 892.1940
- Classification name
- Camera, Focal Spot, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GLASSER
- Address
- 100 Voice Rd. Carle Place NY US 11514 11514
FDA Registration Numbers#
- 3009973336
- 3008788412
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IXH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023390 | MY BREAST FRIEND, BREAST SELF-EXAM PAD | Mbf Sales, LLC | 2002-11-26 |
Legacy Summary#
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FDA Review#
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