The following data is part of a premarket notification filed by Medical Designs L.l.c. with the FDA for Subdural Evacuating Port System, Model 11-9901.
| Device ID | K002970 |
| 510k Number | K002970 |
| Device Name: | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDICAL DESIGNS L.L.C. 213 SUNSET DR. Brandon, SD 57005 |
| Contact | Paul John Axt |
| Correspondent | Paul John Axt MEDICAL DESIGNS L.L.C. 213 SUNSET DR. Brandon, SD 57005 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-22 |
| Decision Date | 2000-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994505217 | K002970 | 000 |