FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEEDLE SAFETY COVER
K Number: K950098
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
2
Review Days
213
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Basic Information
- Device Name
- NEEDLE SAFETY COVER
- K Number
- K950098
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hammer-Plane, Inc.
- Date Received
- January 10, 1995
- Decision Date
- August 11, 1995
- Product Code
- CBT
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
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Other Clearances by Hammer-Plane, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933781 | ANTI-DISCONNECTION MECHANISM | Sep 22, 1993 | Substantially Equivalent |