HEMO-NATE L-P KIT
FDA 510(k) clearance K821814 · decided 1982-07-09
Clearance details
- K-number
- K821814
- Device name
- HEMO-NATE L-P KIT
- Applicant
- Int'L Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-18
- Decision date
- 1982-07-09
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KDD
- Device class
- 1
- Regulation number
- 878.4800
- 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
| Record | Firm | Date |
|---|---|---|
| Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray recall (Z-0233-2016) | Utah Medical Products, Inc | 2015-11-06 |