FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR
K Number: K951140
·
Decision May 25, 1995
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
1
Review Days
73
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Basic Information
- Device Name
- KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR
- K Number
- K951140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Balagan Medical, Inc.
- Date Received
- March 13, 1995
- Decision Date
- May 25, 1995
- Product Code
- HFW
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
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