PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
FDA 510(k) clearance K950178 · decided 1995-07-17
Clearance details
- K-number
- K950178
- Device name
- PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
- Applicant
- Pharma-Plast Intl. A/S
- Decision
- Substantially Equivalent
- Date received
- 1995-01-17
- Decision date
- 1995-07-17
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- LZE
- Device class
- 1
- Regulation number
- 888.1520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Londonderry, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.