FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOELAST 5-0 SUTURE, MODEL 500100
K Number: K072470
·
Decision Nov 16, 2007
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
4
Review Days
73
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Basic Information
- Device Name
- BIOELAST 5-0 SUTURE, MODEL 500100
- K Number
- K072470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4494
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Entrigue Surgical, Inc.
- Date Received
- September 4, 2007
- Decision Date
- November 16, 2007
- Product Code
- NWJ
- 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 |
|---|---|---|---|
| NWJ | Suture, Recombinant Technology | FDA class 2 | General, Plastic Surgery |
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