FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLASTIC MOUTH BARRIER HCV-E
K Number: K860780
·
Decision Apr 2, 1986
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- PLASTIC MOUTH BARRIER HCV-E
- K Number
- K860780
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Westmark Enterprises, Inc.
- Date Received
- March 3, 1986
- Decision Date
- April 2, 1986
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
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