The following data is part of a premarket notification filed by Vygon Us Llc with the FDA for Modification To Lumbo-peritoneal Shunts And Lumbar Drainage Catheters.
| Device ID | K033704 |
| 510k Number | K033704 |
| Device Name: | MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | VYGON US LLC 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON US LLC 2495 GENERAL ARMSTEAD AVE. Norristown, PA 19403 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2004-05-27 |