THERAPEUTIC EXCHANGE SYSTEM
FDA 510(k) clearance K831423 · decided 1984-01-03
Clearance details
- K-number
- K831423
- Device name
- THERAPEUTIC EXCHANGE SYSTEM
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-03
- Decision date
- 1984-01-03
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- LQQ
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.