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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K903448
Device Name SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
Applicant
Medical Engineering Corp.
3003 Rollie Gates Dr.
Paso Robles,  CA  93446
Applicant Contact SALLY A SALISBURY
Correspondent
Medical Engineering Corp.
3003 Rollie Gates Dr.
Paso Robles,  CA  93446
Correspondent Contact SALLY A SALISBURY
Classification Product Code
LCJ  
Date Received07/31/1990
Decision Date 01/14/1991
Decision Substantially Equivalent (SESE)
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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