510(k) K200680
K200680 is an FDA 510(k) premarket notification submitted by Origio A/S, A Coopersurgical Company for the device "Synvitro Hyadase". The FDA issued a decision of Substantially Equivalent on Jul 17, 2020. 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
- Jul 17, 2020
- Date Received
- Mar 16, 2020
- Clearance Type
- Special
- 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)