STERILESERT(TM) CABLE AND POLE DRAPE— 510(k) K913047

Name: FDA 510(k) clearance K913047
Creator: U.S. Food and Drug Administration
Published: 1991-10-02

Substantially Equivalent

Arch Development Group

FDA 510(k) clearance K913047 for STERILESERT(TM) CABLE AND POLE DRAPE, Substantially Equivalent on 1991-10-02. Applicant: Arch Development Group. Device class: 2.

Clearance details

Applicant: Arch Development Group
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1991-07-09
Decision date: 1991-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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