FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMART KLAMP VARIOUS BY SIZE
K Number: K032091
·
Decision Mar 8, 2004
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
2
Review Days
245
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Basic Information
- Device Name
- SMART KLAMP VARIOUS BY SIZE
- K Number
- K032091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emergogroup, Inc.
- Date Received
- July 7, 2003
- Decision Date
- March 8, 2004
- 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 Emergogroup, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042917 | STAT MEDICAL PEN NEEDLE | Apr 22, 2005 | Substantially Equivalent |