Cleared Traditional

DEROYAL SURGICAL DRAPES BACKTABLE COVER

K030908 · Deroyal · General Hospital
Aug 2003
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K030908 is an FDA 510(k) clearance for the DEROYAL SURGICAL DRAPES BACKTABLE COVER, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Deroyal (Knoxville, US). The FDA issued a Cleared decision on August 11, 2003, 140 days after receiving the submission on March 24, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K030908 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2003
Decision Date August 11, 2003
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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