KOALA CLAMP
FDA 510(k) clearance K010695 · decided 2001-05-03
Clearance details
- K-number
- K010695
- Device name
- KOALA CLAMP
- Applicant
- Maternus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-08
- Decision date
- 2001-05-03
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HFW
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Antonio, TX, US
- 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.