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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 K790842
Device Name SUBCUTANEOUS TISSUE EXPANDER
Applicant
Heyer Schulte Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Heyer Schulte Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LCJ  
Date Received05/02/1979
Decision Date 08/03/1979
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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