FDA 510(k) Application Details - K003871

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K003871
Device Name Laparoscope, General & Plastic Surgery
Applicant APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 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 12/15/2000
Decision Date 05/31/2001
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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