FDA 510(k) K250555, MallyaD injection pen adapter (MallyaD), by Biocorp Production

FDA 510(k) K250555, MallyaD injection pen adapter (MallyaD), by Biocorp Production

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Device Classification Name: Injection Data Capture Device
510(k) Number: K250555
Device Name: MallyaD injection pen adapter (MallyaD)
Applicant: Biocorp Production
Regulation Number: 880.5860
Classification Product Code: QOG
Date Received: 02/25/2025
Decision Date: 03/27/2025
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: General Hospital

Total number of pages: 254
Fully redacted pages: 171
Content pages: 83

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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