The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for Catheters, H-h Ventricular.
| Device ID | K782105 |
| 510k Number | K782105 |
| Device Name: | CATHETERS, H-H VENTRICULAR |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | HOLTER-HAUSNER INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-19 |
| Decision Date | 1979-01-15 |