HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
FDA 510(k) clearance K011573 · decided 2001-07-02
Clearance details
- K-number
- K011573
- Device name
- HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM
- Applicant
- Conception Technologies
- Decision
- Substantially Equivalent
- Date received
- 2001-05-21
- Decision date
- 2001-07-02
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.