FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVAC-TUBE
K Number: K894032
·
Decision Aug 31, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
4
Review Days
86
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Basic Information
- Device Name
- EVAC-TUBE
- K Number
- K894032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5650
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sharn, Inc.
- Date Received
- June 6, 1989
- Decision Date
- August 31, 1989
- Product Code
- CAO
- 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 |
|---|---|---|---|
| CAO | Airway, Esophageal (Obturator) | FDA class 2 | Anesthesiology |
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