510(k) K022480

ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC by Acmi Corporation — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2002
Date Received
July 26, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type