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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 K833502
Device Name RADOVAN SUBCUTANEOUS TISSUE EXPANDER
Applicant
American Heyer Schulte
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Heyer Schulte
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LCJ  
Date Received10/05/1983
Decision Date 02/03/1984
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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