The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Polypropylene Burr Hole Reservoir.
| Device ID | K925810 |
| 510k Number | K925810 |
| Device Name: | CORDIS POLYPROPYLENE BURR HOLE RESERVOIR |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-17 |
| Decision Date | 1994-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830056205 | K925810 | 000 |
| 00382830056199 | K925810 | 000 |
| 00382830056182 | K925810 | 000 |
| 00382830055222 | K925810 | 000 |
| 10381780034575 | K925810 | 000 |
| 10381780034568 | K925810 | 000 |
| 10381780034551 | K925810 | 000 |
| 10381780034544 | K925810 | 000 |