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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name box, battery, rechargeable
510(k) Number K946080
Device Name PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
Applicant
PORTABLE POWER SYSTEMS, INC.
1940 TEE LN.
CASTLE ROCK,  CO  80104
Applicant Contact NORMAN A PREMOP
Correspondent
PORTABLE POWER SYSTEMS, INC.
1940 TEE LN.
CASTLE ROCK,  CO  80104
Correspondent Contact NORMAN A PREMOP
Regulation Number876.1500
Classification Product Code
FCO  
Date Received12/13/1994
Decision Date 08/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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