510(k) K983713
K983713 is an FDA 510(k) premarket notification submitted by Prodimed for the device "PRODIMED MICROINJECTION PIPETTES". The FDA issued a decision of Substantially Equivalent on Jun 8, 1999. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 1999
- Date Received
- Oct 21, 1998
- 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
- 510(k)