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FDA 510(k) Application Details - K983367
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K983367
Device Name
Container, Sharps
Applicant
HANDREN ASSOC.
5818 PR. CAROLINE PL.
LEESBURG, FL 34748 US
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Contact
ROBERT T HANDREN JR
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
MMK
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More FDA Info for this Product Code
Date Received
09/24/1998
Decision Date
11/06/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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