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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K926333
Device Name CPR PLUS
Applicant
Kells Medical, Inc.
C/O Law Ofc. Keller & Heckman
1001 G St., NW, Suite 500 W.
Washington,  DC  20001
Applicant Contact JOHN B DUNBECK
Correspondent
Kells Medical, Inc.
C/O Law Ofc. Keller & Heckman
1001 G St., NW, Suite 500 W.
Washington,  DC  20001
Correspondent Contact JOHN B DUNBECK
Regulation Number870.5210
Classification Product Code
LIX  
Date Received12/16/1992
Decision Date 11/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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