S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
FDA 510(k) clearance K955164 · decided 1996-03-20
Clearance details
- K-number
- K955164
- Device name
- S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
- Applicant
- Habley Medical Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-13
- Decision date
- 1996-03-20
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.