ENTACT SEPTAL STAPLER, MODEL 610-00100— 510(k) K082750

Name: FDA 510(k) clearance K082750
Creator: U.S. Food and Drug Administration
Published: 2009-01-06

Substantially Equivalent

Entrigue Surgical, Inc.

FDA 510(k) clearance K082750 for ENTACT SEPTAL STAPLER, MODEL 610-00100, Substantially Equivalent on 2009-01-06. Applicant: Entrigue Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Entrigue Surgical, Inc.
Product code: Code OLL
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2008-09-19
Decision date: 2009-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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