The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Shunt Passers.
| Device ID | K841553 |
| 510k Number | K841553 |
| Device Name: | H-H SHUNT PASSERS |
| Classification | Instrument, Shunt System Implantation |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-16 |
| Decision Date | 1984-05-14 |