510(k) K013536
K013536 is an FDA 510(k) premarket notification submitted by Gynetics Medical Products NV for the device "EMTRAC; DELPHIN; SEMTRAC 2000 SET". The FDA issued a decision of Substantially Equivalent on November 30, 2001. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Gynetics Medical Products NV has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2001
- Date Received
- October 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6110
- Review Panel
- OB
- Submission Type