The following data is part of a premarket notification filed by Weyerhaeuser Co. with the FDA for Maxi Shields.
Device ID | K831593 |
510k Number | K831593 |
Device Name: | MAXI SHIELDS |
Classification | Pad, Menstrual, Unscented |
Applicant | WEYERHAEUSER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-17 |
Decision Date | 1983-08-12 |