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Found 2 results

510(k) Data Aggregation

K Number

Device Name

COAXIAL DILATOR SET

Manufacturer

XENTEK MEDICAL, INC.

Date Cleared

2000-08-01

(147 days)

Product Code

DRE

Regulation Number

870.1310

Why did this record match?

Applicant Name (Manufacturer) :

XENTEK MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

TEARAWAY INTRODUCER SHEATH

Manufacturer

XENTEK MEDICAL, INC.

Date Cleared

2000-06-16

(136 days)

Product Code

DYB

Regulation Number

870.1340

Why did this record match?

Applicant Name (Manufacturer) :

XENTEK MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

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