MALE LATEX CONDOM— 510(k) K012653
Substantially EquivalentQingdao Shuang Die Latex Production Co.,Ltd
FDA 510(k) clearance K012653 for MALE LATEX CONDOM, Substantially Equivalent on 2001-09-21. Applicant: Qingdao Shuang Die Latex Production Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Qingdao Shuang Die Latex Production Co.,Ltd
- 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
- Abbreviated
- Location
- Durham, NC, US
Recent devices under product code HIS
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