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Found 1 results

510(k) Data Aggregation

K Number

Device Name

Natural rubber latex male condom

Manufacturer

Shaoguan Regenex Pharmaceuticals Co., Ltd.

Date Cleared

2025-07-11

(185 days)

Product Code

HIS

Regulation Number

884.5300

Why did this record match?

Applicant Name (Manufacturer) :

Shaoguan Regenex Pharmaceuticals Co., Ltd.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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