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FDA 510(k) Application Details - K980783
Device Classification Name
Absorber, Saliva, Paper
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510(K) Number
K980783
Device Name
Absorber, Saliva, Paper
Applicant
IRT MANAGEMENT CORP.
470 ANSIN BLVD., SUITE G
HALLANDALE, FL 33009 US
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Contact
NICHOLAS G LEVANDOSKI, PH.D.
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Regulation Number
872.6050
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Classification Product Code
KHR
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More FDA Info for this Product Code
Date Received
03/02/1998
Decision Date
04/21/1998
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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