510(k) K863034
K863034 is an FDA 510(k) premarket notification submitted by Chathamborough Research Group, Inc. for the device "SHARPOINT STAINLESS STEEL SUTURE". The FDA issued a decision of Substantially Equivalent on September 30, 1986. The device falls under product code GAO (Suture, Nonabsorbable), a Class II device regulated under 21 CFR 878.4495. Chathamborough Research Group, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1986
- Date Received
- August 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable
- Device Class
- Class II
- Regulation Number
- 878.4495
- Review Panel
- SU
- Submission Type