Cleared Traditional

K094026 - STERI-DENT, STERI-SURE
(FDA 510(k) Clearance)

K094026 · Cpac, Inc. · General Hospital
Jul 2011
Decision
559d
Days
Class 2
Risk

K094026 is an FDA 510(k) clearance for the STERI-DENT, STERI-SURE, a Sterilizer, Dry Heat (Class II — Special Controls, product code KMH), submitted by Cpac, Inc. (Leicester, US). The FDA issued a Cleared decision on July 12, 2011, 559 days after receiving the submission on December 30, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6870.

Submission Details

510(k) Number K094026 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2009
Decision Date July 12, 2011
Days to Decision 559 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KMH — Sterilizer, Dry Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6870

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