FDA 510(k), K023232, SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

FDA 510(k), K023232, SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

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510(K) Number: K023232
Device Name: SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
Manufacturer: KIM SULLIVAN
Device Classification Name: Unit, Oral Irrigation
Regulation Number: EFS
Classification Product Code: KXA
Date Received: 09/27/2002
Decision Date: 12/11/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental

Total pages: 81
Fully redacted pages: 37
Content pages: 44

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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