AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)— 510(k) K980988

Name: FDA 510(k) clearance K980988
Creator: U.S. Food and Drug Administration
Published: 1998-05-11

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K980988 for AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS), Substantially Equivalent on 1998-05-11. Applicant: Axya Medical, Inc.. Device class: 1.

Clearance details

Applicant: Axya Medical, Inc.
Product code: Code GAB
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1998-03-17
Decision date: 1998-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marblehead, MA, US

Download summary PDF View on FDA.gov ↗

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