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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS

Manufacturer

LONDON INTERNATIONAL U.S. HOLDINGS, INC.

Date Cleared

1996-07-22

(353 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

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

DUREX, RAMSES, SHEIK

Manufacturer

LONDON INTERNATIONAL U.S. HOLDINGS, INC.

Date Cleared

1996-07-15

(419 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K020659,K982924,K983380

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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