ENDOBOOT— 510(k) K951104

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K951104 for ENDOBOOT, Substantially Equivalent on 1995-04-06. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code OCU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-10
Decision date: 1995-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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