SAFE GUARD
FDA 510(k) clearance K812722 · decided 1981-11-05
Clearance details
- K-number
- K812722
- Device name
- SAFE GUARD
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-28
- Decision date
- 1981-11-05
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- 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.
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 |