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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 K951878
Device Name SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
Applicant
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Applicant Contact THERESA NAZAROFF
Correspondent
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact THERESA NAZAROFF
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/06/1995
Decision Date 06/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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