FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPIDURAL ANESTHESIA TRAY
K Number: K854518
·
Decision Dec 23, 1985
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
4
Review Days
41
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Basic Information
- Device Name
- EPIDURAL ANESTHESIA TRAY
- K Number
- K854518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Omnis Surgical, Inc.
- Date Received
- November 12, 1985
- Decision Date
- December 23, 1985
- Product Code
- CAZ
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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