510(k) K905024
K905024 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "TMP MANDIBULAR COMPRESSION SYSTEM". The FDA issued a decision of SN on June 24, 1991. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Techmedica, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- June 24, 1991
- Date Received
- November 7, 1990
- 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