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 |