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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 K902349
Device Name SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
Applicant
Surgitek
3003 Rollie Gates Dr.
Paso Robles,  CA  93446
Applicant Contact A SALISBURY
Correspondent
Surgitek
3003 Rollie Gates Dr.
Paso Robles,  CA  93446
Correspondent Contact A SALISBURY
Regulation Number878.4800
Classification Product Code
FZW  
Date Received05/25/1990
Decision Date 09/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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