510(k) K962528
- Device
- OLYMPUS MOBILE CHAIR/COUCH
- Applicant
- KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
- 510(k) number
- K962528
- Product code
- FZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-12-12
- Date received
- 1996-06-27
- Regulation
- 878.4950
- Classification name
- Chair, Surgical, Non-electrical
- Medical specialty
- General & Plastic Surgery
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGER GRAY
- Address
- Stock Rd. Southend-On-Sea, Essex GB SS2 5QH SS2 5QH
FDA Registration Numbers#
- 9680168
- 1836161
- 3011215096
- 3004034546
- 3014273557
- 1926681
- 3008559238
- 2183191
- 3006515340
- 3010493153
- 2031508
- 9681454
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FZK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842030 | NEUTRAL POS-CHAIR SURGEON CHAIR | Neutral Pos-Chair Co. | 1984-07-23 |
Legacy Summary#
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FDA Review#
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