510(k) K854121
K854121 is an FDA 510(k) premarket notification submitted by Prevo Micro-Mat System for the device "MICRO-MAT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1985. The device falls under product code GKJ (Spinner, Slide, Automated), a Class I device regulated under 21 CFR 864.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1985
- Date Received
- October 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinner, Slide, Automated
- Device Class
- Class I
- Regulation Number
- 864.5850
- Review Panel
- HE
- Submission Type