FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
U&U Sterilization Pouch and Roll
K Number: K143637
·
Decision Sep 9, 2015
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
10
Review Days
261
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Basic Information
- Device Name
- U&U Sterilization Pouch and Roll
- K Number
- K143637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&U Medical Technology Co, Ltd.
- Date Received
- December 22, 2014
- Decision Date
- September 9, 2015
- 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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| K152808 | U&U Insulin Syringe with/without Safety Retractable Device | Mar 25, 2016 | Substantially Equivalent |
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| K143629 | U&U Bowie-Dick Test Pack | May 19, 2015 | Substantially Equivalent |
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | Feb 27, 2014 | Substantially Equivalent |
| K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | Feb 26, 2014 | Substantially Equivalent |
| K132552 | U&U STERILE HYPODERMIC NEEDLE | Nov 13, 2013 | Substantially Equivalent |