The following data is part of a premarket notification filed by Mar-med Co. with the FDA for Mar-med Liver Strap.
Device ID | K924223 |
510k Number | K924223 |
Device Name: | MAR-MED LIVER STRAP |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | MAR-MED CO. 353 FULLER N.E. Grand Rapids, MI 49503 |
Contact | Joseph B Marogil |
Correspondent | Joseph B Marogil MAR-MED CO. 353 FULLER N.E. Grand Rapids, MI 49503 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-21 |
Decision Date | 1993-03-18 |