FDA 510(k) Application Details - K950378

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K950378
Device Name Laparoscope, General & Plastic Surgery
Applicant ARGUS MEDICAL CO., INC.
385 S. LEMON AVE.
SUITE E-219
WALNUT, CA US
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Contact WILLIAM MEYER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/31/1995
Decision Date 02/09/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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