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510(k) Data Aggregation

K Number

Device Name

HELIX HYDRO-JET

Manufacturer

ANDREAS PEIN MEDIZINTECHNIK GMBH

Date Cleared

2001-10-10

(70 days)

Product Code

FQH

Regulation Number

880.5475

Why did this record match?

Applicant Name (Manufacturer) :

ANDREAS PEIN MEDIZINTECHNIK GMBH

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The Helix Hydro-Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.

Device Description

Not Found

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