FDA 510(k), K002255, LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

FDA 510(k), K002255, LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K002255
Device Name: LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
Manufacturer:
Device Classification Name: Applicator (Laryngo-Tracheal), Topical Anesthesia
Regulation Number: 868.5170
Classification Product Code: CCT
Date Received: 07/25/2000
Decision Date: 09/18/2000
Regulation Medical Specialty: Anesthesiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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