FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K Number: K960466
·
Decision May 29, 1996
Classifications
1
FEI Numbers
176
Registration Numbers
176
Same Product Code
200
Applicant Total
857
Review Days
148
Basic Information
- Device Name
- IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
- K Number
- K960466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ABBOTT LABORATORIES
- Date Received
- January 2, 1996
- Decision Date
- May 29, 1996
- 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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