FDA 510(k), K903056, BACTTRAP

FDA 510(k), K903056, BACTTRAP

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Device Classification Name: Filter, Bacterial, Breathing-Circuit
510(k) Number: K903056
Device Name: BACTTRAP
Applicant: PHARMA SYSTEMS, INC.
Regulation Number: 868.5260
Classification Product Code: CAH
Date Received: 07/11/1990
Decision Date: 11/05/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: General Hospital

Pages: 50
Redacted: 20
Content Pages: 30

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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