The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kotex Discrete Digital Tampons, Reg.,super,super+.
Device ID | K930149 |
510k Number | K930149 |
Device Name: | KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ |
Classification | Tampon, 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 | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-12 |
Decision Date | 1994-03-02 |