FDA 510(k) Application Details - K983731

Device Classification Name Unit, Operative Dental

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510(K) Number K983731
Device Name Unit, Operative Dental
Applicant PALL MEDICAL
2200 NORTHERN BLVD.
EAST HILLS, NY 11548-1209 US
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Contact ROBERT A DICKSTEIN
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 10/22/1998
Decision Date 12/21/1998
Decision SESE - SUBST EQUIV
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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