FDA 510(k), K160433, V-PRO® 1 Plus and V-PRO® maX Low Temperature
FDA 510(k), K160433, V-PRO® 1 Plus and V-PRO® maX Low Temperature
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510(K) Number: K160433
Device Name: V-PRO® 1 Plus and V-PRO® maX Low Temperature
Manufacturer: STERIS CORPORATION
Device Classification Name: Sterilizer, Chemical
Regulation Number: 880.6860
Classification Product Code: MLR
Date Received: 02/16/2016
Decision Date: 07/06/2016
Regulation Medical Specialty: General Hospital
317 pages (719 of 1,036 original pages are fully redacted)