FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
K Number: K092827
·
Decision Jan 8, 2010
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
9
Applicant Total
1
Review Days
116
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Basic Information
- Device Name
- DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
- K Number
- K092827
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4400
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dimeda Instrumente GmbH
- Date Received
- September 14, 2009
- Decision Date
- January 8, 2010
- Product Code
- HDA
- 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 |
|---|---|---|---|
| HDA | Forceps, Obstetrical | FDA class 2 | Obstetrics/Gynecology |
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