LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM— 510(k) K070800
Substantially EquivalentAnsell Healthcare Products, LLC
FDA 510(k) clearance K070800 for LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM, Substantially Equivalent on 2008-03-06. Applicant: Ansell Healthcare Products, LLC. Device class: 2.
Clearance details
- Applicant
- Ansell Healthcare Products, LLC
- Product code
- Code MOL
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Dothan, AL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.