510(k) K863393

ENDOCATER by The Hygenic Corp. — Product Code LQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1987
Date Received
September 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Root Apex
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type