FDA 510(k), K190917, V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

FDA 510(k), K190917, V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

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510(K) Number: K190917
Device Name: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
Manufacturer: STERIS Corporation
Device Classification Name: sterilizer, chemical
Regulation Number: 880.6860
Classification Product Code: MLR
Date Received: 04/09/2019
Decision Date: 05/09/2019
Regulation Medical Specialty: General Hospital

Total pages: 158  
Fully redacted pages: 108  
Content pages: 50  

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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