FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Non absorbable Surgical Polypropylene Suture
K Number: K230746
·
Decision Sep 14, 2023
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
3
Review Days
181
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Basic Information
- Device Name
- Non absorbable Surgical Polypropylene Suture
- K Number
- K230746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shandong Haidike Medical Products Co., Ltd.
- Date Received
- March 17, 2023
- Decision Date
- September 14, 2023
- Product Code
- GAW
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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