FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM FLOW COUPLER DEVICE AND SYSTEM
K Number: K093310
·
Decision Feb 1, 2010
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
4
Review Days
102
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Basic Information
- Device Name
- GEM FLOW COUPLER DEVICE AND SYSTEM
- K Number
- K093310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synovis Micro Companies Alliance, Inc.
- Date Received
- October 22, 2009
- Decision Date
- February 1, 2010
- Product Code
- MVR
- 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 |
|---|---|---|---|
| MVR | Device, Anastomotic, Microvascular | FDA class 2 | General, Plastic Surgery |
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