510(k) K941193

EAST WEST INSTRUMENTS by East West Instruments, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1994
Date Received
March 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type