Cleared Traditional

PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS

K963458 · Skil-Care Corp. · General Hospital
Oct 1996
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K963458 is an FDA 510(k) clearance for the PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Skil-Care Corp. (Yonkers, US). The FDA issued a Cleared decision on October 18, 1996, 45 days after receiving the submission on September 3, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number K963458 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1996
Decision Date October 18, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMQ — Restraint, Protective
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6760

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