510(k) K143629
K143629 is an FDA 510(k) premarket notification submitted by U&U Medical Technology Co, Ltd. for the device "U&U Bowie-Dick Test Pack". The FDA issued a decision of Substantially Equivalent on May 19, 2015. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. U&U Medical Technology Co, Ltd. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2015
- Date Received
- Dec 22, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
- 510(k)