IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
FDA 510(k) clearance K955380 · decided 1996-05-14
Clearance details
- K-number
- K955380
- Device name
- IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
- Applicant
- International Biophysics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-24
- Decision date
- 1996-05-14
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.