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Found 2 results

510(k) Data Aggregation

K Number

Device Name

TEMNO ACHIEVE BIOPSY NEEDLE

Manufacturer

BAUER MEDICAL, INC.

Date Cleared

1996-04-05

(91 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

BAUER MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Device Name

TEMNO DOUBLE SHOT BIOPSY NEEDLE

Manufacturer

BAUER MEDICAL, INC.

Date Cleared

1996-04-05

(91 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

BAUER MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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