510(k) K000540
K000540 is an FDA 510(k) premarket notification submitted by Arc Medical Supplies (Beijing) Co, Ltd. for the device "POLYESTER NONABSORBABLE SURGICAL SUTURES, USP". The FDA issued a decision of SN on Apr 27, 2000. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Arc Medical Supplies (Beijing) Co, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- Apr 27, 2000
- Date Received
- Feb 17, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type