Device |
suture, surgical, absorbable, polydioxanone |
Regulation Description |
Absorbable polydioxanone surgical suture. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
General & Plastic Surgery |
Product Code | NEW |
Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
510(k)
|
Regulation Number |
878.4840
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |