Cleared Traditional

Family of Steam Sterilizers B 28 series

K151597 · Cefla S.C. · General Hospital
Mar 2016
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K151597 is an FDA 510(k) clearance for the Family of Steam Sterilizers B 28 series, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on March 4, 2016, 266 days after receiving the submission on June 12, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K151597 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2015
Decision Date March 04, 2016
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6880

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