The following data is part of a premarket notification filed by Holter-hausner Intl. with the FDA for H-h Unitized Standard Shunt/reservoir Shunt.
| Device ID | K853366 |
| 510k Number | K853366 |
| Device Name: | H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT |
| Classification | Shunt, Central Nervous System And Components |
| 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 | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-09-11 |