FDA 510(k), K132920, SPIROX INEX DEVICE

FDA 510(k), K132920, SPIROX INEX DEVICE

Regular price $655.09 USD
Regular price Sale price $655.09 USD
Sale Sold out

510(K) Number: K132920
Device Name: SPIROX INEX DEVICE
Manufacturer: SPIROX, INC.
Device Classification Name: polymer, ear, nose and throat, synthetic, absorbable
Regulation Number: 874.3620
Classification Product Code: NHB
Date Received: 09/17/2013
Decision Date: 06/10/2014
Regulation Medical Specialty: Ear Nose & Throat

Total pages: 2,214  
Fully redacted pages: 1,932  
Content pages: 282 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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