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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 K944418
Device Name THE SPACEMAKER AND THE SPACEMAKER II
Applicant
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Applicant Contact THERESA M NAZAROFF
Correspondent
General Surgical Innovations
3172a Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact THERESA M NAZAROFF
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/08/1994
Decision Date 11/01/1994
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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