FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K Number: K011105
·
Decision May 30, 2001
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
29
Applicant Total
1
Review Days
49
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Basic Information
- Device Name
- SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
- K Number
- K011105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qrc Consulting
- Date Received
- April 11, 2001
- Decision Date
- May 30, 2001
- Product Code
- GAL
- 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 |
|---|---|---|---|
| GAL | Suture, Absorbable, Natural | FDA class 2 | General, Plastic Surgery |
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