The following data is part of a premarket notification filed by Visitec Co. with the FDA for Needles, Cannulas, Cystotomes.
| Device ID | K782169 |
| 510k Number | K782169 |
| Device Name: | NEEDLES, CANNULAS, CYSTOTOMES |
| Classification | Cannula, Ophthalmic |
| Applicant | VISITEC CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-29 |
| Decision Date | 1979-02-13 |