BOUINS SOLUTION
FDA 510(k) clearance K833515 · decided 1983-11-14
Clearance details
- K-number
- K833515
- Device name
- BOUINS SOLUTION
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-11
- Decision date
- 1983-11-14
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- IGN
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| VOLU-SOL BOVINS FIXATIVE (K822129) | Volu Sol Medical Industries | 1982-08-05 |
Recalls involving this device
No recalls on record reference this clearance.