510(k) K831423
- Device
- THERAPEUTIC EXCHANGE SYSTEM
- Applicant
- EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
- 510(k) number
- K831423
- Product code
- LQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-03
- Date received
- 1983-05-03
- Regulation
- 510(k) Premarket Notification
- Classification name
- Columns, Immunoadsorption In Extracorporeal Systems
- 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
- Gastroenterology/Urology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3019016592
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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