510(k) K992307
K992307 is an FDA 510(k) premarket notification submitted by Fertility Technology Resources, Inc. for the device "EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Fertility Technology Resources, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1999
- Date Received
- July 9, 1999
- 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