The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap- Meithke Progav Programmable Shunt System.
| Device ID | K103003 |
| 510k Number | K103003 |
| Device Name: | AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2010-11-09 |
| Summary: | summary |