510(k) K994148
K994148 is an FDA 510(k) premarket notification submitted by Implant Innovations, Inc. for the device "3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2000. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Implant Innovations, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2000
- Date Received
- December 8, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type