TORQUE PLUS CATALOG 30120
FDA 510(k) clearance K833940 · decided 1983-12-28
Clearance details
- K-number
- K833940
- Device name
- TORQUE PLUS CATALOG 30120
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-15
- Decision date
- 1983-12-28
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- HWE
- Device class
- 1
- Regulation number
- 878.4820
- 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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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |