FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
K Number: K953786
·
Decision Sep 19, 1995
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
5
Review Days
36
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Basic Information
- Device Name
- UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
- K Number
- K953786
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unicor, Inc.
- Date Received
- August 14, 1995
- Decision Date
- September 19, 1995
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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Other Clearances by Unicor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953784 | UNICOR, INC. CORRUGATED TUBING | Sep 19, 1995 | Substantially Equivalent |
| K953787 | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | Sep 19, 1995 | Substantially Equivalent |
| K953788 | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | Sep 19, 1995 | Substantially Equivalent |
| K953785 | UNICOR, INC. VENTILATOR HOSES | Sep 18, 1995 | Substantially Equivalent |