STOPEX-CONDOMS-— 510(k) K834591
Substantially EquivalentTropex Worldwide, Inc.
FDA 510(k) clearance K834591 for STOPEX-CONDOMS-, Substantially Equivalent on 1984-02-04. Applicant: Tropex Worldwide, Inc.. Device class: 2.
Clearance details
- Applicant
- Tropex Worldwide, Inc.
- Product code
- Code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code HIS
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