FDA 510K (K980987) BECTON DICKINSON SYRINGE

FDA 510K (K980987) BECTON DICKINSON SYRINGE

Regular price $191.03 USD
Regular price Sale price $191.03 USD
Sale Sold out

Device Classification Name    Syringe, Piston
510(k) Number    K980987
Device Name    BECTON DICKINSON SYRINGE
Applicant    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Regulation Number    880.5860
Classification Product Code    FMF  
Date Received    03/17/1998
Decision Date    06/11/1998
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    General Hospital

Total pages: 161
Fully redacted pages: 104
Content pages: 57

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

View full details