510(k) K102480
INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA by
Jieying Laboratory, Inc.
— Product Code MQH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2011
- Date Received
- August 30, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microtools, Assisted Reproduction (Pipettes)
- Device Class
- Class II
- Regulation Number
- 884.6130
- Review Panel
- OB
- Submission Type