FDA 510(k) Application Details - K990379

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K990379
Device Name Laparoscope, General & Plastic Surgery
Applicant DEXIDE, INC.
7509 FLAGSTONE DR.
FORT WORTH, TX 76118 US
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Contact JOHN CORZINE
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 02/08/1999
Decision Date 03/04/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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