FDA 510(k) Application Details - K955825

Device Classification Name Processor, Radiographic-Film, Automatic, Dental

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510(K) Number K955825
Device Name Processor, Radiographic-Film, Automatic, Dental
Applicant SMITH COMPANIES DENTAL PRODUCTS
43257 OSGOOD RD.
FREMONT, CA 94539 US
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Contact BARRY J WALTER
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Regulation Number 892.1900

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Classification Product Code EGY
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Date Received 12/26/1995
Decision Date 04/05/1996
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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