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Found 2 results

510(k) Data Aggregation

K Number

Device Name

VTU-1 VACUUM ERECTION SYSTEM

Manufacturer

MCKENNA & CUNEO

Date Cleared

1997-10-03

(182 days)

Product Code

LKY

Regulation Number

876.5020

Why did this record match?

Applicant Name (Manufacturer) :

**MCKENNA **& CUNEO

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The VTU-1 is intended to aid in the production and maintenance of a penile erection in individuals suffering from impotence.

Device Description

Not Found

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K Number

Device Name

MANUAL MASSAGE ROLLER

Manufacturer

MCKENNA & CUNEO

Date Cleared

1996-01-29

(794 days)

Product Code

LYG

Regulation Number

890.5660

Why did this record match?

Applicant Name (Manufacturer) :

**MCKENNA **& CUNEO

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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