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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 K970754
Device Name INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
Applicant
INNERDYNE, INC.
5060 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact RICK GAYKOWSKI
Correspondent
INNERDYNE, INC.
5060 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact RICK GAYKOWSKI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/03/1997
Decision Date 04/21/1997
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
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