Cleared Traditional

CORE PREVENT MATTRESS MODIFICATION

K935220 · Paladin Medical, Inc. · General Hospital
Nov 1993
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K935220 is an FDA 510(k) clearance for the CORE PREVENT MATTRESS MODIFICATION, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 29, 1993, 48 days after receiving the submission on October 12, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number K935220 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1993
Decision Date November 29, 1993
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

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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