FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
K Number: K130097
·
Decision Jul 22, 2014
Classifications
1
FEI Numbers
466
Registration Numbers
466
Same Product Code
680
Applicant Total
1
Review Days
553
Basic Information
- Device Name
- MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
- K Number
- K130097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED
- Date Received
- January 15, 2013
- Decision Date
- July 22, 2014
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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