Cleared Traditional

INFANT LIMB HOLDER, MODELS 306080 & 306081

K010818 · Skil-Care Corp. · General Hospital
May 2001
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K010818 is an FDA 510(k) clearance for the INFANT LIMB HOLDER, MODELS 306080 & 306081, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Skil-Care Corp. (Yonkers, US). The FDA issued a Cleared decision on May 24, 2001, 66 days after receiving the submission on March 19, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number K010818 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2001
Decision Date May 24, 2001
Days to Decision 66 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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