FDA 510(k) Application Details - K941349

Device Classification Name Unit, Operative Dental

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510(K) Number K941349
Device Name Unit, Operative Dental
Applicant CUSH MEDICAL PRODUCTS
881 MOUNTAIN VIEW DR.
PINEY FLATS, TN US
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Contact STEVE B JOHNSTON
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 03/21/1994
Decision Date 07/26/1994
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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