FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
K Number: K831071
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
12
Applicant Total
5
Review Days
65
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Basic Information
- Device Name
- UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
- K Number
- K831071
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4525
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Prothia USA, Inc.
- Date Received
- April 4, 1983
- Decision Date
- June 8, 1983
- Product Code
- GZX
- 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 |
|---|---|---|---|
| GZX | Instrument, Microsurgical | FDA class 1 | Neurology |
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