FDA 510K (K950178) PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
FDA 510K (K950178) PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
Device Classification Name Isometer
510(k) Number K950178
Device Name PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
Applicant PHARMA-PLAST INTL. A/S
Regulation Number 888.1520
Classification Product Code LZE
Date Received 01/17/1995
Decision Date 07/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
Total pages: 142
Fully redacted pages: 23
Content pages: 119
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