Product code KIM
- Device name
- Device For Sealing Microsections
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3400
- Review panel
- PA
- 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 |
|---|---|---|---|
| K780261 | COVERSLIPPER | Shandon, Inc. | 1978-04-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051663517690 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517836 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517829 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517812 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517805 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517799 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517782 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517775 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517768 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517751 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517744 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517737 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517720 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517713 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517706 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517362 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517539 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517522 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517515 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517492 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517485 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517478 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517461 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517454 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517447 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517430 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517423 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517393 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517386 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |
| 05051663517379 | Epredia | SHANDON DIAGNOSTICS LIMITED | 2024-02-16 |