Cleared Traditional

DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE

K033057 · Deroyal · General Hospital
Nov 2003
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K033057 is an FDA 510(k) clearance for the DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Deroyal (Knoxville, US). The FDA issued a Cleared decision on November 20, 2003, 52 days after receiving the submission on September 29, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K033057 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2003
Decision Date November 20, 2003
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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