SYDNEY IVF HYALURONIDASE
FDA 510(k) clearance K023353 · decided 2002-12-20
Clearance details
- K-number
- K023353
- Device name
- SYDNEY IVF HYALURONIDASE
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-07
- Decision date
- 2002-12-20
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.