510(k) K990913
K990913 is an FDA 510(k) premarket notification submitted by Laboratoires Prodimed for the device "HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU". The FDA issued a decision of Substantially Equivalent on Jun 8, 1999. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 1999
- Date Received
- Mar 18, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6100
- Review Panel
- OB
- Submission Type
- 510(k)