510(k) K897100

CENTURION VAGINAL SPECULUM by Tri-State Hospital Supply Corp. — Product Code HIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1990
Date Received
December 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal, Fiberoptic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type