FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEUS MALE CONDOM APPLICATOR
K Number: K052206
·
Decision Sep 12, 2006
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
2
Review Days
396
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Basic Information
- Device Name
- ZEUS MALE CONDOM APPLICATOR
- K Number
- K052206
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Condax, LLC
- Date Received
- August 12, 2005
- Decision Date
- September 12, 2006
- Product Code
- HIS
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Condax, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K031007 | KWIKEZE MALE CONDOM APPLICATOR | Nov 14, 2003 | Substantially Equivalent |