FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K Number: K070800
·
Decision Mar 6, 2008
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
26
Review Days
349
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Basic Information
- Device Name
- LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
- K Number
- K070800
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ansell Healthcare Products, LLC
- Date Received
- March 23, 2007
- Decision Date
- March 6, 2008
- Product Code
- MOL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOL | Condom, Synthetic | FDA class 2 | Obstetrics/Gynecology |
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