The following data is part of a premarket notification filed by Sharpoint, Inc. with the FDA for Coated Suture Needle.
| Device ID | K863595 |
| 510k Number | K863595 |
| Device Name: | COATED SUTURE NEEDLE |
| Classification | Needle, Suturing, Disposable |
| Applicant | SHARPOINT, INC. 2850 WINDMILL RD. Reading, PA 19608 |
| Contact | David A Yates |
| Correspondent | David A Yates SHARPOINT, INC. 2850 WINDMILL RD. Reading, PA 19608 |
| Product Code | GAB |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-15 |
| Decision Date | 1986-10-24 |