FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT
K Number: K880384
·
Decision Jun 23, 1988
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
2
Applicant Total
104
Review Days
147
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Basic Information
- Device Name
- KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT
- K Number
- K880384
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kimberly-Clark Corp.
- Date Received
- January 28, 1988
- Decision Date
- June 23, 1988
- Product Code
- BWP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BWP | Shoe And Shoe Cover, Conductive | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWP), ordered by most recent decision date.
SURGICAL APPAREL SHOE COVERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANOGO DISPOSABLE SHOE COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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|---|---|---|---|
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| 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 |