Cleared Traditional

Tamper Evident Cap with Male Luer Lock

K182545 · International Medical Industries, Inc. · General Hospital
Jan 2019
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K182545 is an FDA 510(k) clearance for the Tamper Evident Cap with Male Luer Lock, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on January 11, 2019, 116 days after receiving the submission on September 17, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K182545 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2018
Decision Date January 11, 2019
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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