MANOMETRIC ASSEMBLIES— 510(k) K983665

Substantially Equivalent

Dentsleeve Pty., Ltd.

FDA 510(k) clearance K983665 for MANOMETRIC ASSEMBLIES, Substantially Equivalent on 1999-05-17. Applicant: Dentsleeve Pty., Ltd.. Device class: 2.

Clearance details

Applicant: Dentsleeve Pty., Ltd.
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1998-10-19
Decision date: 1999-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parkside South Australia, AU

Download summary PDF View on FDA.gov ↗

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