Product code KSD
- Device name
- Device, Heat-Sealing
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.9750
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820301 | PLASMA POOLER HEAT SEALER | North American Biologicals, Inc. | 1982-04-09 |
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