EXTRACORP.'S INTERSEPT CUS. TUBING PK.
FDA 510(k) clearance K800178 · decided 1980-02-21
Clearance details
- K-number
- K800178
- Device name
- EXTRACORP.'S INTERSEPT CUS. TUBING PK.
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-01-28
- Decision date
- 1980-02-21
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- DWE
- Device class
- 2
- Regulation number
- 870.4390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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