TELEVISION CAMERA HOLDER FOR SURGERY
FDA 510(k) clearance K810303 · decided 1981-02-26
Clearance details
- K-number
- K810303
- Device name
- TELEVISION CAMERA HOLDER FOR SURGERY
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-05
- Decision date
- 1981-02-26
- Days to decision
- 21 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
- Mchenry, IL, 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 |
|---|---|---|
| SONI-LOK SCOPE STABILIZER (K850122) | Med Surg Designs, Inc. | 1985-02-21 |
Recalls involving this device
No recalls on record reference this clearance.