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FDA 510(k) Application Details - K972234
Device Classification Name
Syringe, Periodontic, Endodontic, Irrigating
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510(K) Number
K972234
Device Name
Syringe, Periodontic, Endodontic, Irrigating
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK, PA 17405 US
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Contact
P. JEFFERY LEHN
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Regulation Number
872.4565
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Classification Product Code
EIC
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More FDA Info for this Product Code
Date Received
06/16/1997
Decision Date
06/30/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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