FDA 510(k), K110771, BD SINGLE USE, HYPODERMIC SYRINGE

FDA 510(k), K110771, BD SINGLE USE, HYPODERMIC SYRINGE

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510(K) Number: K110771
Device Name: BD SINGLE USE, HYPODERMIC SYRINGE
Manufacturer: Becton, Dickinson and Company
Device Classification Name: Syringe, Piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 03/21/2011
Decision Date: 05/13/2011
Regulation Medical Specialty: General Hospital

Total pages: 167
Fully redacted pages: 29
Content pages: 138

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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