The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Cable Holder, Suction Tube Holder.
| Device ID | K971040 |
| 510k Number | K971040 |
| Device Name: | CABLE HOLDER, SUCTION TUBE HOLDER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. P.O. BOX 56 Grand Blanc, MI 48439 |
| Contact | Micheal Czop |
| Correspondent | Micheal Czop CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. P.O. BOX 56 Grand Blanc, MI 48439 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-21 |
| Decision Date | 1997-04-16 |
| Summary: | summary |