FDA 510(k) Application Details - K961170

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K961170
Device Name Accelerator, Linear, Medical
Applicant S. AND H. ENGINEERING, INC.
4141 NW 132 ST.
MIAMI, FL 33054 US
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Contact SYDNEY GOLDSTEIN
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 03/25/1996
Decision Date 06/19/1996
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

FDA Source Information for K961170


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