FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCC-23 SAFETY CLAMP AND CUTTER
K Number: K982464
·
Decision Aug 11, 1998
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
57
Applicant Total
1
Review Days
27
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Basic Information
- Device Name
- SCC-23 SAFETY CLAMP AND CUTTER
- K Number
- K982464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Women First Healthcare, Inc.
- Date Received
- July 15, 1998
- Decision Date
- August 11, 1998
- Product Code
- KNA
- 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 |
|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | FDA class 2 | Obstetrics/Gynecology |
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