The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for External Ventricular Drainage Sys..
| Device ID | K820247 |
| 510k Number | K820247 |
| Device Name: | EXTERNAL VENTRICULAR DRAINAGE SYS. |
| 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 | 1982-01-29 |
| Decision Date | 1982-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780072409 | K820247 | 000 |
| 10381780071082 | K820247 | 000 |
| 10381780071075 | K820247 | 000 |
| 10381780071068 | K820247 | 000 |
| 10381780071020 | K820247 | 000 |
| 10381780026211 | K820247 | 000 |
| 10381780023890 | K820247 | 000 |
| 10381780023852 | K820247 | 000 |