The following data is part of a premarket notification filed by American V. Mueller with the FDA for Heyer-schulte Syringo Peritoneal Shunt.
| Device ID | K854049 |
| 510k Number | K854049 |
| Device Name: | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT |
| 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 | 1985-10-03 |
| Decision Date | 1985-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780072522 | K854049 | 000 |
| 10381780024460 | K854049 | 000 |