FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMPON, HEAVY DUTY, & STICK
K Number: K780058
·
Decision Jan 26, 1978
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
104
Review Days
14
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Basic Information
- Device Name
- TAMPON, HEAVY DUTY, & STICK
- K Number
- K780058
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kimberly-Clark Corp.
- Date Received
- January 12, 1978
- Decision Date
- January 26, 1978
- Product Code
- HIL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.
ONTEX AND OTHERS PROPRIETARY NAMES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
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PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
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FDA Class 2
·Obstetrics/Gynecology
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Kimberly-Clark Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K140963 | KIMGUARD SMART-FOLD STERILIZATION WRAP | Nov 10, 2014 | Substantially Equivalent |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | Aug 25, 2014 | Substantially Equivalent |
| K131879 | KC 300 SURGICAL MASK | Dec 20, 2013 | Substantially Equivalent |
| K131841 | KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE | Nov 7, 2013 | Substantially Equivalent |
| K131254 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE | Aug 20, 2013 | Substantially Equivalent |
| K120985 | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING | Dec 19, 2012 | Substantially Equivalent |
| K112805 | KIMGUARD ONE-STEP STERILIZATION WRAP | Jun 22, 2012 | Substantially Equivalent |
| K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | Mar 9, 2012 | Substantially Equivalent |
| K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | Jan 19, 2012 | Substantially Equivalent |
| K112635 | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS | Oct 7, 2011 | Substantially Equivalent |