BITE BLOCK— 510(k) K954352

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K954352 for BITE BLOCK, Substantially Equivalent on 1996-01-25. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 1995-09-18
Decision date: 1996-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.