510(k) K173043
K173043 is an FDA 510(k) premarket notification submitted by Nantong Holycon Medical Devices Co., Ltd. for the device "Holycon Synthetic Absorbable Sutures". The FDA issued a decision of Substantially Equivalent on Dec 14, 2017. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 14, 2017
- Date Received
- Sep 28, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type
- 510(k)