FDA 510(k) Application Details - K981032

Device Classification Name

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510(K) Number K981032
Device Name PIV SYSTEM
Applicant MEDICAL SOLUTIONS, INC.
P.O BOX 4343
CROFTON, MD 21114 US
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Contact E J SMITH
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Regulation Number

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Classification Product Code LDQ
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Date Received 03/19/1998
Decision Date 09/02/1998
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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