Cleared Traditional

CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025

K010644 · Skil-Care Corp. · General Hospital
May 2001
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K010644 is an FDA 510(k) clearance for the CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025, 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 18, 2001, 74 days after receiving the submission on March 5, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number K010644 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2001
Decision Date May 18, 2001
Days to Decision 74 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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