The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Sexton Scup Urine Mgmt. Sys.
| Device ID | K853458 |
| 510k Number | K853458 |
| Device Name: | H-H SEXTON SCUP URINE MGMT. SYS |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport, PA 19405 |
| Contact | John R Bolles |
| Correspondent | John R Bolles HOLTER-HAUSNER INTL. THIRD AND MILL STREETS P.O. BOX 100 Bridgeport, PA 19405 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1985-08-27 |