FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K Number: K040999
·
Decision Jul 9, 2004
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
23
Review Days
81
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Basic Information
- Device Name
- TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
- K Number
- K040999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Procter & Gamble Co.
- Date Received
- April 19, 2004
- Decision Date
- July 9, 2004
- Product Code
- HEB
- 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Procter & Gamble Co.
| K Number | Device Name | ||
|---|---|---|---|
| K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | Sep 15, 2014 | Substantially Equivalent |
| K131543 | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED | Jun 20, 2013 | Substantially Equivalent |
| K091281 | TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA | Jun 1, 2010 | Substantially Equivalent |
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Sep 24, 2009 | Substantially Equivalent |
| K081555 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | Jun 27, 2008 | Substantially Equivalent |
| K062638 | TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS | Nov 22, 2006 | Substantially Equivalent |
| K061486 | TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) | Aug 1, 2006 | Substantially Equivalent |
| K051290 | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) | Dec 27, 2005 | Substantially Equivalent |
| K040312 | TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS | May 3, 2004 | Substantially Equivalent |
| K012629 | ALWAYS DUETS | Oct 5, 2001 | Substantially Equivalent |