The following data is part of a premarket notification filed by American V. Mueller with the FDA for Heyer-schulte Spetzler Lumbar-peritoneal Shunt Sys.
Device ID | K871685 |
510k Number | K871685 |
Device Name: | HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS |
Classification | Shunt, Central Nervous System And Components |
Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Contact | Matthew Nowland |
Correspondent | Matthew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-29 |
Decision Date | 1987-06-12 |