The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Weck Rack (sterilizing Accessory Tray).
Device ID | K791743 |
510k Number | K791743 |
Device Name: | WECK RACK (STERILIZING ACCESSORY TRAY) |
Classification | Tray, Surgical, Instrument |
Applicant | EDWARD WECK, 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 | 1979-09-10 |
Decision Date | 1979-09-26 |