FDA 510(k), K964445, OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
FDA 510(k), K964445, OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
Device Name: OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
Manufacturer:
Device Classification Name: Instruments, Surgical, Cardiovascular
Regulation Number: 870.4500
Classification Product Code: DWS
Date Received: 11/06/1996
Decision Date: 01/30/1997
Regulation Medical Specialty: Cardiovascular
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details