FDA 510(k), K023083 SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

FDA 510(k), K023083 SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

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Device Classification Name    Pump, Infusion
510(k) Number    K023083
Device Name    SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
Applicant    METTLER ELECTRONICS CORP.
Regulation Number    880.5725
Classification Product Code    FRN  
Subsequent Product Code    IMG  
Date Received    09/17/2002
Decision Date    02/28/2003
Decision    SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty    General Hospital
510k Review Panel    General Hospital

Total pages: 169
Fully redacted pages: 52
Content pages: 117

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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