Cleared Special

Tamper Evident Cap

K193192 · International Medical Industries, Inc. · General Hospital
Jan 2020
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K193192 is an FDA 510(k) clearance for the Tamper Evident Cap, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on January 31, 2020, 73 days after receiving the submission on November 19, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K193192 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2019
Decision Date January 31, 2020
Days to Decision 73 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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