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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 K983385
Device Name HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
Applicant
Hutchison Intl., Inc.
7475 Wisconsin Ave.,
Suite 850
Bethesda,  MD  20814
Applicant Contact EDUARDO MARCH
Correspondent
Hutchison Intl., Inc.
7475 Wisconsin Ave.,
Suite 850
Bethesda,  MD  20814
Correspondent Contact EDUARDO MARCH
Classification Product Code
LCJ  
Date Received09/25/1998
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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