510(k) K823516
- Device
- ESA CAMERA
- Applicant
- CONCEPT, INC.
- 510(k) number
- K823516
- Product code
- FWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-30
- Date received
- 1982-11-29
- Regulation
- 878.4160
- Classification name
- Camera, Cine, Surgical, Without Audio
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3006810260
- 3005778609
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884039 | MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940 | Medical Dynamics, Inc. | 1988-10-13 |
Legacy Summary#
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FDA Review#
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