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

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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

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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