The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for General Equipment Cover.
Device ID | K782155 |
510k Number | K782155 |
Device Name: | GENERAL EQUIPMENT COVER |
Classification | System, X-ray, Mobile |
Applicant | CONTOUR FABRICATORS, INC. 14241 FENTON RD. Fenton, MI 48430 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-22 |
Decision Date | 1979-01-17 |