Cleared Traditional

K101653 - MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
(FDA 510(k) Clearance)

K101653 · Miltex, Inc. · General Hospital
Aug 2010
Decision
52d
Days
Class 2
Risk

K101653 is an FDA 510(k) clearance for the MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on August 2, 2010, 52 days after receiving the submission on June 11, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K101653 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2010
Decision Date August 02, 2010
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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