The following data is part of a premarket notification filed by Bio Medical Devices, Inc. with the FDA for The Reel Thing (modification).
| Device ID | K955439 |
| 510k Number | K955439 |
| Device Name: | THE REEL THING (MODIFICATION) |
| Classification | Catheter, Irrigation |
| Applicant | BIO MEDICAL DEVICES, INC. 1752 A LANGLEY AVE. Irvine, CA 92714 |
| Contact | Nick Herbert |
| Correspondent | Nick Herbert BIO MEDICAL DEVICES, INC. 1752 A LANGLEY AVE. Irvine, CA 92714 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1995-12-26 |