FDA 510(k), K170848, Alzair Allergy Blocker

FDA 510(k), K170848, Alzair Allergy Blocker

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510(K) Number: K170848
Device Name: Alzair Allergy Blocker
Manufacturer: Nasaleze International Ltd
Device Classification Name: cream, nasal, topical, mechanical allergen particle barrier
Regulation Number: 880.5045
Classification Product Code: NUP
Date Received: 03/21/2017
Decision Date: 06/14/2017
Regulation Medical Specialty: General Hospital

Total pages: 162
Fully redacted pages: 28
Content pages: 134

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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