Cleared Traditional

R1124 & R1686 PARAFFIN

K861344 · Tri W-G, Inc. · Physical Medicine
May 1986
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K861344 is an FDA 510(k) clearance for the R1124 & R1686 PARAFFIN, a Bath, Paraffin (Class II — Special Controls, product code IMC), submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on May 27, 1986, 50 days after receiving the submission on April 7, 1986. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number K861344 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1986
Decision Date May 27, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

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

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