FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
K Number: K881429
·
Decision Apr 25, 1988
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
- K Number
- K881429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Repackers Co.
- Date Received
- March 29, 1988
- Decision Date
- April 25, 1988
- 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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