FDA 510(k), K072834, SIBEL SA VASCULAR CLAMP

FDA 510(k), K072834, SIBEL SA VASCULAR CLAMP

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510(K) Number: K072834
Device Name: SIBEL SA VASCULAR CLAMP
Manufacturer: SURGICAL INSTRUMENTS BELGIUM SA
Device Classification Name: clamp, vascular
Regulation Number: 870.4450
Classification Product Code: DXC
Date Received: 10/03/2007
Decision Date: 01/09/2008
Regulation Medical Specialty: Cardiovascular

Total pages: 175
Fully redacted pages: 56 (≤ 50 words or fully redacted)
Content pages: 119

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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