510(k) K905024

TMP MANDIBULAR COMPRESSION SYSTEM by Techmedica, Inc. — Product Code HRS

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