FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
K Number: K052192
·
Decision Feb 2, 2006
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
4
Review Days
175
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Basic Information
- Device Name
- FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
- K Number
- K052192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Femspec LLC
- Date Received
- August 11, 2005
- Decision Date
- February 2, 2006
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
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