The following data is part of a premarket notification filed by Chathamborough Research Group, Inc. with the FDA for Sharpoint Stainless Steel Suture.
| Device ID | K863034 |
| 510k Number | K863034 |
| Device Name: | SHARPOINT STAINLESS STEEL SUTURE |
| Classification | Suture, Nonabsorbable |
| Applicant | CHATHAMBOROUGH RESEARCH GROUP, INC. 105 WEST ST. P.O. BOX DRAWER 929 Pittsboro, NC 27312 |
| Contact | Tim Hubbard |
| Correspondent | Tim Hubbard CHATHAMBOROUGH RESEARCH GROUP, INC. 105 WEST ST. P.O. BOX DRAWER 929 Pittsboro, NC 27312 |
| Product Code | GAO |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-11 |
| Decision Date | 1986-09-30 |