FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
K Number: K800862
·
Decision May 30, 1980
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
3
Review Days
44
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Basic Information
- Device Name
- 1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
- K Number
- K800862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Custom Medical Devices Intl., Inc.
- Date Received
- April 16, 1980
- Decision Date
- May 30, 1980
- Product Code
- FMG
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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