510(k) K932492
K932492 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "IMPLANTOLOGY MODULE, MODEL 2175". The FDA issued a decision of Substantially Equivalent on October 5, 1993. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1993
- Date Received
- May 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type