The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Cfi Restraint Belt (cfi-168) / Cfi Restraint Belt (cfi-4046).
| Device ID | K963453 |
| 510k Number | K963453 |
| Device Name: | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) |
| Classification | Restraint, Protective |
| Applicant | CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. P.O. BOX 56 Grand Blanc, MI 48439 |
| Contact | Michael Czop |
| Correspondent | Michael Czop CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. P.O. BOX 56 Grand Blanc, MI 48439 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-15 |