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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K970201
Device Name GSI CANNULA WITH INTRODUCER
Applicant
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Applicant Contact CATHLEEN MANTOR
Correspondent
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact CATHLEEN MANTOR
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/21/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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