The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kotex Profile Shaped Maxi Pad.
Device ID | K871210 |
510k Number | K871210 |
Device Name: | KOTEX PROFILE SHAPED MAXI PAD |
Classification | Pad, Menstrual, Unscented |
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 | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-25 |
Decision Date | 1987-04-10 |