Cleared Traditional

DISPOSABLE BEARD COVER

K904276 · Anago, Inc. · General Hospital
Nov 1990
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K904276 is an FDA 510(k) clearance for the DISPOSABLE BEARD COVER, a Hood, Surgical (Class II — Special Controls, product code FXY), submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 21, 1990, 63 days after receiving the submission on September 19, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K904276 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1990
Decision Date November 21, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FXY — Hood, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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