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 |