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FDA 510(k) K990328, DBC, DONG BANG ACUPUNCTURE NEEDLES, by Morning Star, Dong Bang Acupuncture U.S.A., Inc.

FDA 510(k) K990328, DBC, DONG BANG ACUPUNCTURE NEEDLES, by Morning Star, Dong Bang Acupuncture U.S.A., Inc.

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510(K) Number: K990328
Device Name: DBC, DONG BANG ACUPUNCTURE NEEDLES
Manufacturer: Morning Star, Dong Bang Acupuncture U.S.A., Inc.
Device Classification Name: Needle, Acupuncture, Single Use
Regulation Number: 880.5580
Classification Product Code: MQX
Date Received: 02/02/1999
Decision Date: 05/04/1999
Regulation Medical Specialty: General Hospital

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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