FDA 510(k), K130041, SHEATHES STERILE ULTRASOUND GEL

FDA 510(k), K130041, SHEATHES STERILE ULTRASOUND GEL

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510(K) Number: K130041
Device Name: SHEATHES STERILE ULTRASOUND GEL
Manufacturer: SHEATHING TECHNOLOGIES, INC.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 01/08/2013
Decision Date: 02/06/2013
Regulation Medical Specialty: Radiology

Total pages: 181
Fully redacted pages: 68
Content pages: 113

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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