MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
FDA 510(k) clearance K972135 · decided 1997-08-26
Clearance details
- K-number
- K972135
- Device name
- MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
- Applicant
- P/L Biomedical
- Decision
- Substantially Equivalent
- Date received
- 1997-06-06
- Decision date
- 1997-08-26
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fort Myers, FL, US
- Third-party review
- No
- Expedited review
- No
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