Synvitro Hyadase
FDA 510(k) clearance K200680 · decided 2020-07-17
Clearance details
- K-number
- K200680
- Device name
- Synvitro Hyadase
- Applicant
- Origio A/S, A Coopersurgical Company
- Decision
- Substantially Equivalent
- Date received
- 2020-03-16
- Decision date
- 2020-07-17
- Days to decision
- 123 days
- Clearance type
- Special
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Måløv, DK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.