The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for Sexton Cystotomy Urine Pump.
| Device ID | K843158 |
| 510k Number | K843158 |
| Device Name: | SEXTON CYSTOTOMY URINE PUMP |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-10 |
| Decision Date | 1984-10-04 |