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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 K884746
Device Name SURGITEK FLAT T-SPAN
Applicant
Medical Engineering Corp.
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact BETTY A LOCK
Correspondent
Medical Engineering Corp.
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact BETTY A LOCK
Classification Product Code
LCJ  
Date Received11/14/1988
Decision Date 08/10/1989
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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