510(k) K954076

MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS by Midas Rex Pneumatic Tools, Inc. — Product Code GET

K954076 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS". The FDA issued a decision of Substantially Equivalent on October 18, 1995. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1995
Date Received
August 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type