The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap-meithke Progav Programmable Valve, Models Fv410t-fv451t.
| Device ID | K062009 |
| 510k Number | K062009 |
| Device Name: | AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull 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 | 2006-07-17 |
| Decision Date | 2007-01-17 |
| Summary: | summary |