Cleared Abbreviated

PRESTIGE AMERITECH FACE MASK

K061716 · Prestige Ameritech · General Hospital
Aug 2006
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K061716 is an FDA 510(k) clearance for the PRESTIGE AMERITECH FACE MASK, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Prestige Ameritech (Fort Worth, US). The FDA issued a Cleared decision on August 14, 2006, 56 days after receiving the submission on June 19, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K061716 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2006
Decision Date August 14, 2006
Days to Decision 56 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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