Cleared Traditional

ANTI-INFECTION SHIELD

K872935 · Stackhouse Assoc. · General Hospital
Nov 1987
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K872935 is an FDA 510(k) clearance for the ANTI-INFECTION SHIELD, a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Stackhouse Assoc. (El Segundo, US). The FDA issued a Cleared decision on November 9, 1987, 105 days after receiving the submission on July 27, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K872935 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1987
Decision Date November 09, 1987
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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