The following data is part of a premarket notification filed by Markham Service Co., Inc. with the FDA for Conductive Cushion.
Device ID | K780941 |
510k Number | K780941 |
Device Name: | CONDUCTIVE CUSHION |
Classification | Cushion, Flotation |
Applicant | MARKHAM SERVICE CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIC |
CFR Regulation Number | 890.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-07 |
Decision Date | 1978-07-27 |