Cleared Traditional

REUSABLE INCONTIENT UNDERPAD

K924807 · Perfect Fit Industries, Inc. · General Hospital
Feb 1993
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K924807 is an FDA 510(k) clearance for the REUSABLE INCONTIENT UNDERPAD, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Perfect Fit Industries, Inc. (Monroe, US). The FDA issued a Cleared decision on February 10, 1993, 160 days after receiving the submission on September 3, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number K924807 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1992
Decision Date February 10, 1993
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMW — Cover, Mattress (medical Purposes)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6190

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