Cleared Traditional

PARA-CARE

K980718 · Chattanooga Group, Inc. · Physical Medicine
Mar 1998
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K980718 is an FDA 510(k) clearance for the PARA-CARE, a Bath, Paraffin (Class II — Special Controls, product code IMC), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on March 27, 1998, 31 days after receiving the submission on February 24, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number K980718 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1998
Decision Date March 27, 1998
Days to Decision 31 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IMC — Bath, Paraffin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5110

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