The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Needle Range (gasterurology).
| Device ID | K811965 |
| 510k Number | K811965 |
| Device Name: | VISITEC NEEDLE RANGE (GASTERUROLOGY) |
| Classification | Needle, Gastro-urology |
| Applicant | VISITEC CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FHR |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-10 |
| Decision Date | 1981-08-25 |