510(k) K882407

BOW & ARROW DRILL GUIDE by Instrument Makar, Inc. — Product Code LXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1988
Date Received
June 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Drill, Ligament
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type