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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 K962702
Device Name SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
Applicant
General Surgical Innovations
3172-A Porter Dr.
Palo Alto,  CA  94304
Applicant Contact CATHLEEN MANTOR
Correspondent
General Surgical Innovations
3172-A Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact CATHLEEN MANTOR
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/12/1996
Decision Date 02/19/1997
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
Predetermined Change
Control Plan Authorized		 No
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