FDA 510(k), K142282, HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)

FDA 510(k), K142282, HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)

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510(K) Number: K142282
Device Name: HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
Manufacturer:
Device Classification Name: Tube, Tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 08/15/2014
Decision Date: 04/23/2015
Regulation Medical Specialty: Ear Nose & Throat

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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