ECOMED SCALP VEIN SET
FDA 510(k) clearance K992145 · decided 1999-10-14
Clearance details
- K-number
- K992145
- Device name
- ECOMED SCALP VEIN SET
- Applicant
- Greiner Meditech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-24
- Decision date
- 1999-10-14
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bel Air, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Holdex + Butterfly, Blood Collection Set, Single use only. Sterile, Manufactured by : CA G recall (Z-0388-04) | Greiner VACUETTE North America | 2004-01-29 |