510(k) K001912
K001912 is an FDA 510(k) premarket notification submitted by Narishige Co., Ltd. for the device "IM-9B MICROINJECTORS". The FDA issued a decision of Substantially Equivalent on July 7, 2000. The device falls under product code MQJ (Micromanipulators And Microinjectors, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6150. Narishige Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2000
- Date Received
- June 23, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Micromanipulators And Microinjectors, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6150
- Review Panel
- OB
- Submission Type