FDA 510(k), K904774, INGLAT-O-BALL

FDA 510(k), K904774, INGLAT-O-BALL

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510(K) Number: K904774
Device Name: INGLAT-O-BALL
Manufacturer: GARY CHUVEN
Device Classification Name: Pessary, Vaginal
Regulation Number: HHW
Classification Product Code: KXA
Date Received: 10/22/1990
Decision Date: 12/07/1990
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology

Total pages: 21

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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