FDA 510(k), K030474, PH BUFFERING PLASTIC APPLICATOR TAMPON

FDA 510(k), K030474, PH BUFFERING PLASTIC APPLICATOR TAMPON

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510(K) Number: K030474
Device Name: PH BUFFERING PLASTIC APPLICATOR TAMPON
Manufacturer: ROSTAM LTD.
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: 884.5470
Classification Product Code: HEB
Date Received: 02/12/2003
Decision Date: 05/28/2004
Regulation Medical Specialty: Obstetrics/Gynecology

Total Pages: 198
Fully Redacted Pages: 30
Content Pages: 168

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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