NOVATOME, MODEL: SU101-50— 510(k) K072051

Name: FDA 510(k) clearance K072051
Creator: U.S. Food and Drug Administration
Published: 2007-10-03

Substantially Equivalent

Scholten Surgical Instruments, Inc.

FDA 510(k) clearance K072051 for NOVATOME, MODEL: SU101-50, Substantially Equivalent on 2007-10-03. Applicant: Scholten Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Scholten Surgical Instruments, Inc.
Product code: Code DWZ
Device class: Class 2
Regulation: 21 CFR 870.4075
Advisory panel: Cardiovascular
Date received: 2007-07-26
Decision date: 2007-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lodi, CA, US

Download summary PDF View on FDA.gov ↗

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