FDA 510(k) Application Details - K993037

Device Classification Name

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510(K) Number K993037
Device Name LCV+ VERSION 2
Applicant GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact LARRY A KROGER
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Regulation Number

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Classification Product Code OWB
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Date Received 09/09/1999
Decision Date 02/14/2000
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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