The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kotex(r) Securehold Super Curve/curved Maxi Pads.
Device ID | K925250 |
510k Number | K925250 |
Device Name: | KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS |
Classification | Pad, Menstrual, Unscented |
Applicant | KIMBERLY-CLARK CORP. 700 11TH STREET, NW SUITE 660 Washington, DC 20001 |
Contact | Bonnie B Wan |
Correspondent | Bonnie B Wan KIMBERLY-CLARK CORP. 700 11TH STREET, NW SUITE 660 Washington, DC 20001 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-16 |
Decision Date | 1993-03-03 |