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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL

Manufacturer

MISTEN MEDICAL CORP.

Date Cleared

1996-07-25

(51 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE

Manufacturer

MISTEN MEDICAL CORP.

Date Cleared

1996-01-17

(37 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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