FDA 510(k) Application Details - K955236

Device Classification Name Monitor, Patient Position, Light-Beam

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510(K) Number K955236
Device Name Monitor, Patient Position, Light-Beam
Applicant MEDTEC, INC.
P.O. BOX 487
1401 8TH STREET SOUTH EAST
ORANGE CITY, IA 51041-0487 US
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Contact DONALD F RIIBE
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Regulation Number 892.5780

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Classification Product Code IWE
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Date Received 11/14/1995
Decision Date 05/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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