510(k) K051742
K051742 is an FDA 510(k) premarket notification submitted by Inntec, Inc. for the device "OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Inntec, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2005
- Date Received
- June 28, 2005
- Clearance Type
- Abbreviated
- 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