FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]
K Number: K945949
·
Decision Jul 25, 1995
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
2
Review Days
231
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Basic Information
- Device Name
- KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]
- K Number
- K945949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vlm Surgical, Inc.
- Date Received
- December 6, 1994
- Decision Date
- July 25, 1995
- Product Code
- HFX
- 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 |
|---|---|---|---|
| HFX | Clamp, Circumcision | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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SHANGRING
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Other Clearances by Vlm Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842912 | THE SUTURER | Aug 15, 1984 | Substantially Equivalent |