| Device Type ID | 2389 |
| Device Name | Device, Heat-sealing |
| Regulation Description | Heat-sealing Device. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.9750 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KSD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2389 |
| Device | Device, Heat-sealing |
| Product Code | KSD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Heat-sealing Device. |
| CFR Regulation Number | 864.9750 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |