The following data is part of a premarket notification filed by Sorex Medical with the FDA for Edlich Wound Management Tray.
Device ID | K905572 |
510k Number | K905572 |
Device Name: | EDLICH WOUND MANAGEMENT TRAY |
Classification | Wound Dressing Kit |
Applicant | SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
Contact | Joseph Sorenson |
Correspondent | Joseph Sorenson SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
Product Code | MCY |
CFR Regulation Number | 880.5075 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-12 |
Decision Date | 1991-03-12 |