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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 K960232
Device Name ENDOSCOPIC ACCESS DEVICE
Applicant
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Applicant Contact KATHY FELTRIN
Correspondent
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Correspondent Contact KATHY FELTRIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/17/1996
Decision Date 03/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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