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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expander, Surgical, Skin Graft
510(k) Number K972109
Device Name SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
Applicant
General Surgical Innovations
10460 Bubb Rd.
Cupertino,  CA  95014
Applicant Contact CATHLEEN MANTOR
Correspondent
General Surgical Innovations
10460 Bubb Rd.
Cupertino,  CA  95014
Correspondent Contact CATHLEEN MANTOR
Regulation Number878.4800
Classification Product Code
FZW  
Date Received06/05/1997
Decision Date 11/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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