510(k) K983181

CYTOPREP by Cytoprep Inc. Est. — Product Code HHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1998
Date Received
September 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type