FDA 510(k) Application Details - K823581

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K823581
Device Name Laparoscope, General & Plastic Surgery
Applicant PROTHIA USA, INC.

, US
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 12/06/1982
Decision Date 03/24/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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