The following data is part of a premarket notification filed by Inmed Ltda. with the FDA for Csf400 And Csf600.
| Device ID | K030081 |
| 510k Number | K030081 |
| Device Name: | CSF400 AND CSF600 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INMED LTDA. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour INMED LTDA. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-09 |
| Decision Date | 2003-10-06 |
| Summary: | summary |