510(k) K042527

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 by Medical Action Industries, Inc. — Product Code HHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2004
Date Received
September 17, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Cervical, Cytological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type