FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
K Number: K023868
·
Decision Feb 7, 2003
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
35
Applicant Total
1
Review Days
79
Basic Information
- Device Name
- DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
- K Number
- K023868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DANNORITZER MEDICAL INSTRUMENTS
- Date Received
- November 20, 2002
- Decision Date
- February 7, 2003
- Product Code
- HAE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAE | Rongeur, Manual | FDA class 2 | Neurology |
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