The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Reigel Tunneling Device.
| Device ID | K962761 |
| 510k Number | K962761 |
| Device Name: | REIGEL TUNNELING DEVICE |
| Classification | Instrument, Shunt System Implantation |
| Applicant | COOK, INC. P.O. BOX 489 Bloomington, IN 47402 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-10-11 |
| Summary: | summary |