KOTEX OVERNITE
FDA 510(k) clearance K860587 · decided 1986-03-13
Clearance details
- K-number
- K860587
- Device name
- KOTEX OVERNITE
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-19
- Decision date
- 1986-03-13
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- HHD
- Device class
- 1
- Regulation number
- 884.5435
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Neenah, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALWAYS MENSTRUAL PADS (K071827) | Procter & Gamble, Inc. | 2007-09-20 |
| ALWAYS DUETS (K012629) | Procter & Gamble Co. | 2001-10-05 |
| ENVIVE MINIFORMS (K003843) | Procter & Gamble Co. | 2001-02-08 |
| UNSCENTED INTERLABIAL MENSTRUAL PAD (K993870) | Procter & Gamble Co. | 2000-01-18 |
| GLADRAGS COTTON MENSTRUAL PAD (K980395) | Keepers!, Inc. | 1998-04-16 |
| FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (K953470) | Mediquip, Inc. | 1995-11-21 |
| UNSCENTED ULTRATHIN MAXI PAD (K953668) | Paragon Trade Brands, Inc. | 1995-11-01 |
| UNSCENTED MENSTRUAL PAD (K953633) | Tendasoft, Inc. | 1995-11-01 |
| UNSCENTED CURVED ULTRATHIN MAXI PADS (K953667) | Paragon Trade Brands, Inc. | 1995-11-01 |
| UNSCENTED MENSTRAL PAD (K953553) | Paragon Trade Brands, Inc. | 1995-10-27 |
| UNSCENTED MENSTRUAL PAD (K953517) | Paragon Trade Brands, Inc. | 1995-10-26 |
| UNSCENTED CURVED MAXI PAD (K953700) | Paragon Trade Brands, Inc. | 1995-09-27 |
Recalls involving this device
No recalls on record reference this clearance.