FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANIPUSEAL
K Number: K051160
·
Decision Sep 2, 2005
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
17
Applicant Total
1
Review Days
120
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Basic Information
- Device Name
- MANIPUSEAL
- K Number
- K051160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1640
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Insitu Systems
- Date Received
- May 5, 2005
- Decision Date
- September 2, 2005
- Product Code
- HEW
- 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 |
|---|---|---|---|
| HEW | Culdoscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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