FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
HEART PACK II
K Number: K914935
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
7
Review Days
88
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Basic Information
- Device Name
- HEART PACK II
- K Number
- K914935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Westmark Hospital Supplies
- Date Received
- November 4, 1991
- Decision Date
- January 31, 1992
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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