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510(k) Data Aggregation

K Number

Device Name

INSTEAD, SOFTCUP

Manufacturer

ULTRAFEM, INC.

Date Cleared

1997-06-06

(59 days)

Product Code

HHE

Regulation Number

884.5400

Why did this record match?

Applicant Name (Manufacturer) :

ULTRAFEM, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

For use as a form of feminine protection, commonly employed to collect blood, help prevent leakage and to prevent staining and spotting of clothing.

Device Description

Not Found

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