FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUARDIAN PEEL POUCHES
K Number: K803293
·
Decision Jan 28, 1981
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
104
Review Days
29
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Basic Information
- Device Name
- GUARDIAN PEEL POUCHES
- K Number
- K803293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kimberly-Clark Corp.
- Date Received
- December 30, 1980
- Decision Date
- January 28, 1981
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |