510(k) BK910024
- Device
- Heat Sealing Devices
- Applicant
- Engineering & Research Associates, Inc.
- 510(k) number
- BK910024
- Product code
- KSD
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1992-11-05
- Date received
- 1991-08-23
- Regulation
- 864.9750
- Classification name
- Device, Heat-sealing
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820301 | PLASMA POOLER HEAT SEALER | North American Biologicals, Inc. | 1982-04-09 |
Legacy Summary#
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FDA Review#
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