The following data is part of a premarket notification filed by Weco with the FDA for Struva & Medi.
Device ID | K811173 |
510k Number | K811173 |
Device Name: | STRUVA & MEDI |
Classification | Bandage, Elastic |
Applicant | WECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FQM |
CFR Regulation Number | 880.5075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-28 |
Decision Date | 1981-06-18 |