Cleared Traditional

R1363 PARAFFIN

K861346 · Tri W-G, Inc. · Physical Medicine
May 1986
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K861346 is an FDA 510(k) clearance for the R1363 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 2, 1986, 25 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 K861346 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1986
Decision Date May 02, 1986
Days to Decision 25 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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