510(k) K936050

JAW SPREADER by Gam Industries, Inc. — Product Code KBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Oral
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type