FDA 510(k) Application Details - K962120

Device Classification Name Unit, X-Ray, Extraoral With Timer

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510(K) Number K962120
Device Name Unit, X-Ray, Extraoral With Timer
Applicant STERI-OSS, INC.
22895 EASTPARK DR.
YORBA LINDA, CA 92887 US
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Contact PAUL GASSER
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 05/31/1996
Decision Date 07/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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