FDA 510(k) Application Details - K992852

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K992852
Device Name Laparoscope, General & Plastic Surgery
Applicant APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS, CA 92653 US
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Contact ANIL BHALANI
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 08/24/1999
Decision Date 11/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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