FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
K Number: K063223
·
Decision Jan 23, 2008
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
41
Review Days
456
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Basic Information
- Device Name
- MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
- K Number
- K063223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5350
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CooperSurgical, Inc.
- Date Received
- October 24, 2006
- Decision Date
- January 23, 2008
- Product Code
- HDW
- 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 |
|---|---|---|---|
| HDW | Diaphragm, Contraceptive (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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