FDA 510(k) Application Details - K991612

Device Classification Name Container, Sharps

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510(K) Number K991612
Device Name Container, Sharps
Applicant STERILOGIC WASTE SYSTEMS, INC.
9948 KISTLER VALLEY RD., #102
KEMPTON, PA 19529-0084 US
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Contact CALVIN A ODHNER
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 05/10/1999
Decision Date 05/28/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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