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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 K961940
Device Name INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
Applicant
Innerdyne, Inc.
5060 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact RICK GAYKOWSKI
Correspondent
Innerdyne, Inc.
5060 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact RICK GAYKOWSKI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/20/1996
Decision Date 07/10/1996
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
Recalls CDRH Recalls
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