The following data is part of a premarket notification filed by Theramed, Inc. with the FDA for Hydrocephalus Shunt System, Low/medium/high Press..
| Device ID | K895524 |
| 510k Number | K895524 |
| Device Name: | HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS. |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | THERAMED, INC. P.O. BOX 5886 Ft. Lauderdale, FL 33310 |
| Contact | Charles Hokanson |
| Correspondent | Charles Hokanson THERAMED, INC. P.O. BOX 5886 Ft. Lauderdale, FL 33310 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-12 |
| Decision Date | 1990-04-10 |