Standard Staple-Line Reinforcement (SSLR23)— 510(k) K231603

Name: FDA 510(k) clearance K231603
Creator: U.S. Food and Drug Administration
Published: 2023-10-06

Substantially Equivalent

Standard Bariatrics, Inc.

FDA 510(k) clearance K231603 for Standard Staple-Line Reinforcement (SSLR23), Substantially Equivalent on 2023-10-06. Applicant: Standard Bariatrics, Inc.. Device class: 2.

Clearance details

Applicant: Standard Bariatrics, Inc.
Product code: Code OXC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2023-06-01
Decision date: 2023-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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