FDA 510(k) Application Details - K963952

Device Classification Name

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510(K) Number K963952
Device Name SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
Applicant GE DEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY, UT 84116 US
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Contact TED L PARROT
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Regulation Number

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Classification Product Code OWB
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Date Received 10/02/1996
Decision Date 12/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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