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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K993688
Device Name AED LAPAROSCOPE
Applicant
National Advanced Endoscopy Devices, Inc.
10801 National Blvd., #603
Los Angeles,  CA  90064
Applicant Contact GAYLE M BUTLER
Correspondent
National Advanced Endoscopy Devices, Inc.
10801 National Blvd., #603
Los Angeles,  CA  90064
Correspondent Contact GAYLE M BUTLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/01/1999
Decision Date 12/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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