Cleared Traditional

ANAGO FEM-COOL/FEM-COOL PETITE

K926137 · Anago, Inc. · Physical Medicine
May 1993
Decision
170d
Days
Class 1
Risk

About This 510(k) Submission

K926137 is an FDA 510(k) clearance for the ANAGO FEM-COOL/FEM-COOL PETITE, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 26, 1993, 170 days after receiving the submission on December 7, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number K926137 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1992
Decision Date May 26, 1993
Days to Decision 170 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IMD — Pack, Hot Or Cold, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5710

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