The following data is part of a premarket notification filed by Medical Sterilization, Inc. with the FDA for Msi Surgi-grade Incision & Drain Tray.
Device ID | K843563 |
510k Number | K843563 |
Device Name: | MSI SURGI-GRADE INCISION & DRAIN TRAY |
Classification | Tray, Surgical, Instrument |
Applicant | MEDICAL STERILIZATION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-10 |
Decision Date | 1984-10-23 |