FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K Number: K853770
·
Decision Oct 6, 1986
Classifications
1
FEI Numbers
63
Registration Numbers
64
Same Product Code
102
Applicant Total
145
Review Days
392
Basic Information
- Device Name
- CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
- K Number
- K853770
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- September 9, 1985
- Decision Date
- October 6, 1986
- Product Code
- GWM
- 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
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