510(k) K850122
- Device
- SONI-LOK SCOPE STABILIZER
- Applicant
- MED SURG DESIGNS, INC.
- 510(k) number
- K850122
- Product code
- FXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-21
- Date received
- 1985-01-14
- Regulation
- 878.4160
- Classification name
- Holder, Camera, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 124 Parker Ct. Chardon OH US 44024 44024
FDA Registration Numbers#
- 3011193403
- 3005587147
- 1220246
- 1836161
- 8040278
- 1320894
- 3015231789
- 9710055
- 3015425104
- 2916714
- 3031563141
- 3020703212
- 1320468
- 1926681
- 1017294
- 8030607
- 9613079
- 3011092264
- 3010331645
- 3012345110
- 3035786158
- 9610612
- 3015972835
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810303 | TELEVISION CAMERA HOLDER FOR SURGERY | The Anspach Effort, Inc. | 1981-02-26 |
Legacy Summary#
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FDA Review#
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