The following data is part of a premarket notification filed by Chathamborough Research Group, Inc. with the FDA for Sharpoint Polypropylene Nonabsorb Surg Sutures Usp.
| Device ID | K904906 |
| 510k Number | K904906 |
| Device Name: | SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-25 |
| Decision Date | 1990-12-24 |