510(k) K212603
K212603 is an FDA 510(k) premarket notification submitted by Shandong Haidike Medical Product Co., Ltd. for the device "Non Absorbable Surgical Nylon Suture". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Shandong Haidike Medical Product Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2021
- Date Received
- August 17, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Device Class
- Class II
- Regulation Number
- 878.5020
- Review Panel
- SU
- Submission Type