FDA 510(k), K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel

FDA 510(k), K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel

Regular price $694.04 USD
Regular price Sale price $694.04 USD
Sale Sold out

510(K) Number: K163050
Device Name: Advance Medical Designs, Inc. Sterile Ultrasound Gel
Manufacturer: ADVANCE MEDICAL DESIGNS, INC.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 11/01/2016
Decision Date: 10/25/2017
Regulation Medical Specialty: Radiology

Total pages: 984
Fully redacted pages: 677
Content pages: 307

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

View full details