The following data is part of a premarket notification filed by Sharpoint, Inc. with the FDA for Anterior Capsulectomy Cystitome.
| Device ID | K840659 |
| 510k Number | K840659 |
| Device Name: | ANTERIOR CAPSULECTOMY CYSTITOME |
| Classification | Cystotome |
| Applicant | SHARPOINT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-15 |
| Decision Date | 1984-03-16 |