OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
FDA 510(k) clearance K994417 · decided 2000-03-01
Clearance details
- K-number
- K994417
- Device name
- OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-29
- Decision date
- 2000-03-01
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- MQE
- Device class
- 2
- Regulation number
- 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.