FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
IV START KIT CUSTOM SMP # A-Z
K Number: K922533
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
4
Review Days
299
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Basic Information
- Device Name
- IV START KIT CUSTOM SMP # A-Z
- K Number
- K922533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Specialty Medical Products Co.
- Date Received
- May 28, 1992
- Decision Date
- March 23, 1993
- Product Code
- LRS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
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