510(k) K883514
K883514 is an FDA 510(k) premarket notification submitted by Exakt Medical Instruments, Inc. for the device "EXAKT CUTTING & GRINDING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 1988. The device falls under product code IDP (Microtome, Cryostat), a Class I device regulated under 21 CFR 864.3010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 1988
- Date Received
- August 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microtome, Cryostat
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type