FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACOR, CANNULA, BICEPTS BIPOLAR
K Number: K790043
·
Decision Feb 8, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
15
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- TRACOR, CANNULA, BICEPTS BIPOLAR
- K Number
- K790043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Neomed Corp.
- Date Received
- January 5, 1979
- Decision Date
- February 8, 1979
- Product Code
- HIN
- 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 |
|---|---|---|---|
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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