SONI-LOK SCOPE STABILIZER
FDA 510(k) clearance K850122 · decided 1985-02-21
Clearance details
- K-number
- K850122
- Device name
- SONI-LOK SCOPE STABILIZER
- Applicant
- Med Surg Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-14
- Decision date
- 1985-02-21
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- FXR
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chardon, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TELEVISION CAMERA HOLDER FOR SURGERY (K810303) | The Anspach Effort, Inc. | 1981-02-26 |
Recalls involving this device
No recalls on record reference this clearance.