510(k) K951701

FMS ARTHRO-CUTTER by Future Medical Systems, Inc. — Product Code HNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1995
Date Received
April 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Depressor, Orbital
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type