FDA 510(k), K173450, PRESS DUO elite, PRESS DUO elite AG

FDA 510(k), K173450, PRESS DUO elite, PRESS DUO elite AG

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510(K) Number: K173450
Device Name: PRESS DUO elite, PRESS DUO elite AG
Manufacturer: Nemoto Kyorindo Co., Ltd.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 11/06/2017
Decision Date: 02/07/2018
Regulation Medical Specialty: Cardiovascular

Total pages: 1,421
Fully redacted pages: 728
Content pages: 693

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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