FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLINE EPIDURAL AND SPINAL NEEDLES
K Number: K110194
·
Decision Jun 17, 2011
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
238
Review Days
144
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Basic Information
- Device Name
- MEDLINE EPIDURAL AND SPINAL NEEDLES
- K Number
- K110194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- January 24, 2011
- Decision Date
- June 17, 2011
- 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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