VACUTOME SUCTION UNIT
FDA 510(k) clearance K791494 · decided 1979-09-07
Clearance details
- K-number
- K791494
- Device name
- VACUTOME SUCTION UNIT
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-02
- Decision date
- 1979-09-07
- Days to decision
- 36 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Concept
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |