FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMECC ENDOCERVICAL CURETTE
K Number: K060320
·
Decision Jul 28, 2006
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
4
Applicant Total
4
Review Days
170
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Basic Information
- Device Name
- FEMECC ENDOCERVICAL CURETTE
- K Number
- K060320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1050
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Femspec LLC
- Date Received
- February 8, 2006
- Decision Date
- July 28, 2006
- Product Code
- PCF
- 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 |
|---|---|---|---|
| PCF | Sampler, Endocervical | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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