510(k) K822857

CPI PRINTER by Cardiac Pacemakers, Inc. — Product Code KAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1983
Date Received
September 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type