FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
K Number: K901810
·
Decision May 30, 1991
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
5
Review Days
405
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Basic Information
- Device Name
- MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
- K Number
- K901810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Neuro Technology
- Date Received
- April 20, 1990
- Decision Date
- May 30, 1991
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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