SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH— 510(k) K030684

Name: FDA 510(k) clearance K030684
Creator: U.S. Food and Drug Administration
Published: 2003-06-03

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K030684 for SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH, Substantially Equivalent on 2003-06-03. Applicant: Acmi Corporation. Device class: 2.

Clearance details

Applicant: Acmi Corporation
Product code: Code OCU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-05
Decision date: 2003-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

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