FDA 510(k) Application Details - K080655

Device Classification Name System, X-Ray, Stationary

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510(K) Number K080655
Device Name System, X-Ray, Stationary
Applicant META IMAGING SOLUTIONS, LLC
30 NECK RD.
OLD LYME, CT 06371 US
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Contact ROBERT J STAAB
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 03/07/2008
Decision Date 05/09/2008
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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