FDA 510(k) Application Details - K994321

Device Classification Name Catheter And Tip, Suction

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510(K) Number K994321
Device Name Catheter And Tip, Suction
Applicant AUTOMATIC LIQUID PACKAGING, INC.
2200 LAKE SHORE DR.
WOODSTOCK, IL 60098 US
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Contact JOHN BRDA
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Regulation Number 880.6740

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Classification Product Code JOL
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Date Received 12/22/1999
Decision Date 10/25/2000
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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