510(k) K894415

DYMAX ENDOVAGINAL BIOPSY GUIDE by Dymax Corp — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type