510(k) K013497
K013497 is an FDA 510(k) premarket notification submitted by Gynetics Medical Products NV for the device "FAS SET #4551". The FDA issued a decision of Substantially Equivalent on November 9, 2001. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Gynetics Medical Products NV has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2001
- Date Received
- October 22, 2001
- 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