The following data is part of a premarket notification filed by Van Dellen, Ltd. with the FDA for Van Dellen Irrigating Cystotome.
| Device ID | K873163 |
| 510k Number | K873163 |
| Device Name: | VAN DELLEN IRRIGATING CYSTOTOME |
| Classification | Cystotome |
| Applicant | VAN DELLEN, LTD. 3810 E. 44TH ST., SUITE 301 P.O. BOX 27748 Tucson, AZ 85726 |
| Contact | Roger Danhof |
| Correspondent | Roger Danhof VAN DELLEN, LTD. 3810 E. 44TH ST., SUITE 301 P.O. BOX 27748 Tucson, AZ 85726 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-11 |
| Decision Date | 1987-09-04 |