The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kotex Security Tube Tampons.
| Device ID | K885194 |
| 510k Number | K885194 |
| Device Name: | KOTEX SECURITY TUBE TAMPONS |
| Classification | Tampon, 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 | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-16 |
| Decision Date | 1989-03-01 |