Kotex Super Maxi Pads
FDA 510(k) K890013 · Kimberly-Clark Corp.
510(k) numberK890013
Submission
- Device name
- Kotex Super Maxi Pads
- Applicant
- Kimberly-Clark Corp.
Washington, DC, US - Received
- January 3, 1989
- Decision date
- April 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHT – Spatula, Cervical, Cytological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| K072381 | Softpap Cervical Cell CollectorHHT · Special | Cytocore, Inc. | 01/30/2008SE |
| K062433 | Diamics Cercol Cervical Sample Collector SystemHHT · Traditional | Diamics, Inc. | 03/16/2007SE |
| K043369 | Cervex-Brush CombiHHT · Traditional | Rovers Medical Devices B.V. | 02/02/2005SE |
| K042527 | Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional | Medical Action Industries, Inc. | 11/08/2004SE |
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Questions and answers
When was Kotex Super Maxi Pads cleared by the FDA?
Kotex Super Maxi Pads (K890013) received a 510(k) decision of Substantially Equivalent on April 25, 1989, 112 days after the submission was received.
What is the product code of K890013?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.