FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLINE NEURO SPONGE
K Number: K140369
·
Decision Sep 26, 2014
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
23
Applicant Total
238
Review Days
224
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Basic Information
- Device Name
- MEDLINE NEURO SPONGE
- K Number
- K140369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- February 14, 2014
- Decision Date
- September 26, 2014
- Product Code
- HBA
- 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 |
|---|---|---|---|
| HBA | Neurosurgical Paddie | FDA class 2 | Neurology |
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