The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Model 6500 Extraction Irrigation Sys.
| Device ID | K791277 |
| 510k Number | K791277 |
| Device Name: | MODEL 6500 EXTRACTION IRRIGATION SYS |
| Classification | Dilator, Cervical, Fixed Size |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HDQ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-10 |
| Decision Date | 1979-08-22 |