FDA 510(k)
FDA class 2
Substantially Equivalent
🇻🇳 Vietnam
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
K Number: K170166
·
Decision Sep 29, 2017
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
142
Applicant Total
1
Review Days
253
Basic Information
- Device Name
- CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
- K Number
- K170166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CPT Sutures Co., Ltd.
- Date Received
- January 19, 2017
- Decision Date
- September 29, 2017
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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