Cleared Traditional

POLYSONIC ULTRASOUND LOTION

K827296 · Parker Laboratories, Inc. · Radiology
Apr 1982
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K827296 is an FDA 510(k) clearance for the POLYSONIC ULTRASOUND LOTION, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on April 16, 1982, 17 days after receiving the submission on March 30, 1982. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K827296 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1982
Decision Date April 16, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code MUI — Media, Coupling, Ultrasound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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