510(k) K914998
K914998 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "MICROAIRE(R) FACIAL BONE PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 1992. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1992
- Date Received
- November 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type