The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap-meithke Prosa Adjustable Shunt System.
| Device ID | K120559 |
| 510k Number | K120559 |
| Device Name: | AESCULAP-MEITHKE PROSA ADJUSTABLE 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-24 |
| Decision Date | 2012-05-24 |
| Summary: | summary |