FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
K Number: K063429
·
Decision Jan 17, 2007
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
4
Review Days
65
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Basic Information
- Device Name
- GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
- K Number
- K063429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Generic Medical Device, Inc.
- Date Received
- November 13, 2006
- Decision Date
- January 17, 2007
- 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 |
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