FDA 510(k), K102871, SILVER CARE ANITBACTERIAL TOOTHBRUSH

FDA 510(k), K102871, SILVER CARE ANITBACTERIAL TOOTHBRUSH

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510(K) Number: K102871
Device Name: SILVER CARE ANITBACTERIAL TOOTHBRUSH
Manufacturer: PIAVE SPAZZOLIFICIO S.P.A.
Device Classification Name: toothbrush, manual
Regulation Number: 872.6855
Classification Product Code: EFW
Date Received: 09/30/2010
Decision Date: 10/03/2011
Regulation Medical Specialty: Dental

Total pages: 177
Fully redacted pages: 39
Content pages: 138

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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