FDA 510(k) Application Details - K992182

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K992182
Device Name Laparoscope, General & Plastic Surgery
Applicant CA GUARD, LTD.
6258 SHADY GROVE RD. E.
MEMPHIS, TN 38120 US
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Contact FRANK M LEWIS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/28/1999
Decision Date 07/18/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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