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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K931483
Device Name REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.
Applicant
Portable Power Systems, Inc.
1949 Tee Ln.
Castle Rock,  CO  80104
Applicant Contact NORMAN A PREMO
Correspondent
Portable Power Systems, Inc.
1949 Tee Ln.
Castle Rock,  CO  80104
Correspondent Contact NORMAN A PREMO
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/24/1993
Decision Date 02/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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