FDA 510(k), K190667, Sonopet iQ Sterilization Tray

FDA 510(k), K190667, Sonopet iQ Sterilization Tray

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510(K) Number: K190667
Device Name: Sonopet iQ Sterilization Tray
Manufacturer: Rebecca Walker
Device Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation Number: KCT
Classification Product Code: KXA
Date Received: 03/15/2019
Decision Date: 06/13/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

Total pages: 526
Fully redacted pages: 240
Content pages: 286

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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