510(k) K930954

THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV by Cabot Medical Corp. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1994
Date Received
February 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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