FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROFIX SURGICAL SHEET
K Number: K100905
·
Decision Jun 2, 2010
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
5
Review Days
62
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Basic Information
- Device Name
- HYDROFIX SURGICAL SHEET
- K Number
- K100905
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mimedx Group, Inc.
- Date Received
- April 1, 2010
- Decision Date
- June 2, 2010
- Product Code
- OMR
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| OMR | Vessel Guard Or Cover | FDA class 2 | Cardiovascular |
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