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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 K843678
Device Name CREAT BRAND SKIN EXPANDER
Applicant
Aesthetech Corp.
P.O. Box 278
Paso Robles,  CA  93447
Applicant Contact THOMAS D SALISBURY
Correspondent
Aesthetech Corp.
P.O. Box 278
Paso Robles,  CA  93447
Correspondent Contact THOMAS D SALISBURY
Classification Product Code
LCJ  
Date Received09/18/1984
Decision Date 11/06/1984
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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