The following data is part of a premarket notification filed by Glamor Plus Co. with the FDA for Disposeable Menstrual Panty.
Device ID | K882109 |
510k Number | K882109 |
Device Name: | DISPOSEABLE MENSTRUAL PANTY |
Classification | Pad, Menstrual, Unscented |
Applicant | GLAMOR PLUS CO. 16422 QUAIL PARK DR. Missouri City, TX 77489 |
Contact | Opel B Goff |
Correspondent | Opel B Goff GLAMOR PLUS CO. 16422 QUAIL PARK DR. Missouri City, TX 77489 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-18 |
Decision Date | 1988-07-26 |