The following data is part of a premarket notification filed by Sharppoint, Inc. with the FDA for Dacron R Surgical Sutures.
| Device ID | K904263 |
| 510k Number | K904263 |
| Device Name: | DACRON R SURGICAL SUTURES |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | SHARPPOINT, INC. P.O. BOX 310 Reading, PA 19607 |
| Contact | Bob Barefoot |
| Correspondent | Bob Barefoot SHARPPOINT, INC. P.O. BOX 310 Reading, PA 19607 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-17 |
| Decision Date | 1990-10-16 |