FDA 510(K) K844550, HOBBS MEDICAL/JAYCO ASPIRATION CATHETER

FDA 510(K) K844550, HOBBS MEDICAL/JAYCO ASPIRATION CATHETER

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Device Classification Name    Endoscopic Irrigation/Suction System
510(k) Number    K844550
Device Name    HOBBS MEDICAL/JAYCO ASPIRATION CATHETER
Applicant    HOBBS MEDICAL, INC.
Regulation Number    876.1500
Classification Product Code    OCX  
Date Received    11/21/1984
Decision Date    01/03/1985
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Gastroenterology/Urology

Total pages: 20
Fully redacted pages: 0
Content pages: 20

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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