FDA 510(k) Application Details - K955363

Device Classification Name Formalin-Saline

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510(K) Number K955363
Device Name Formalin-Saline
Applicant INCSTAR CORP.
1990 INDUSTRIAL BLVD.
P.O. BOX 285
STILLWATER, MN 55082 US
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Contact MARY FRICK
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Regulation Number 864.4010

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Classification Product Code IGC
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Date Received 11/22/1995
Decision Date 07/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PA - Pathology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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