FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
CIT BIOPSY PUNCHES
K Number: K944444
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
21
Applicant Total
4
Review Days
413
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Basic Information
- Device Name
- CIT BIOPSY PUNCHES
- K Number
- K944444
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chirurgische Instrumente
- Date Received
- August 12, 1994
- Decision Date
- September 29, 1995
- Product Code
- HFB
- 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 |
|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | FDA class 1 | Obstetrics/Gynecology |
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