510(k) K180073
K180073 is an FDA 510(k) premarket notification submitted by Shenzhen Vitavitro Bio-Tech Co., Ltd. for the device "Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set". The FDA issued a decision of Substantially Equivalent on Aug 29, 2018. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 2018
- Date Received
- Jan 9, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type
- 510(k)