MOUNTABLE ENDOSCOPIC KNIFE— 510(k) K982142

Substantially Equivalent

A.M. Surgical, Inc.

FDA 510(k) clearance K982142 for MOUNTABLE ENDOSCOPIC KNIFE, Substantially Equivalent on 1998-12-30. Applicant: A.M. Surgical, Inc.. Device class: 1.

Clearance details

Applicant: A.M. Surgical, Inc.
Product code: Code EMF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1998-06-17
Decision date: 1998-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithtown, NY, 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.