The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Fifth Ventricle.
| Device ID | K800168 |
| 510k Number | K800168 |
| Device Name: | H-H FIFTH VENTRICLE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | HOLTER-HAUSNER INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-25 |
| Decision Date | 1980-01-31 |