The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Ventricular Catheter Set.
| Device ID | K962097 |
| 510k Number | K962097 |
| Device Name: | VENTRICULAR CATHETER SET |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | COOK, INC. P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender, Rac |
| Correspondent | April Lavender, Rac COOK, INC. P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-29 |
| Decision Date | 1996-08-29 |
| Summary: | summary |