The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Spetzler Lumbar-peritoneal System.
| Device ID | K811288 |
| 510k Number | K811288 |
| Device Name: | SPETZLER LUMBAR-PERITONEAL SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | AMERICAN HEYER SCHULTE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-11 |
| Decision Date | 1981-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830057219 | K811288 | 000 |
| 00382830057103 | K811288 | 000 |
| 10381780072195 | K811288 | 000 |
| 10381780071211 | K811288 | 000 |