FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIELDED PIGGYBACK IV NEEDLE
K Number: K900353
·
Decision Jun 22, 1990
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
1
Review Days
148
Basic Information
- Device Name
- SHIELDED PIGGYBACK IV NEEDLE
- K Number
- K900353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- PASCALL SARINGIA MEDICAL CORP.
- Date Received
- January 25, 1990
- Decision Date
- June 22, 1990
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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