The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kotex Super Maxi Pads.
Device ID | K890013 |
510k Number | K890013 |
Device Name: | KOTEX SUPER MAXI PADS |
Classification | Spatula, Cervical, Cytological |
Applicant | KIMBERLY-CLARK CORP. 1201 PENNSYLVANIA AVENUE, N.W. SUITE 730 Washington, DC 20004 |
Contact | Bonnie B Wan |
Correspondent | Bonnie B Wan KIMBERLY-CLARK CORP. 1201 PENNSYLVANIA AVENUE, N.W. SUITE 730 Washington, DC 20004 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-03 |
Decision Date | 1989-04-25 |