FDA 510(k) Application Details - K981596

Device Classification Name Cord, Retraction

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510(K) Number K981596
Device Name Cord, Retraction
Applicant ULTRADENT PRODUCTS, INC.
505 W. 10200 SO.
SOUTH JORDAN, UT 84095-3935 US
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Contact CHESTER MCCOY
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Regulation Number 000.0000

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Classification Product Code MVL
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Date Received 05/04/1998
Decision Date 07/31/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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