FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOUBLE-JECT TRANSFER NEEDLE
K Number: K860113
·
Decision Feb 12, 1986
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
4
Review Days
30
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Basic Information
- Device Name
- DOUBLE-JECT TRANSFER NEEDLE
- K Number
- K860113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medimix Products, Inc.
- Date Received
- January 13, 1986
- Decision Date
- February 12, 1986
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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