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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 K853014
Device Name MCGHAN TISSUE EXPANDER FILL KIT
Applicant
MCGHAN MEDICAL CORP.
700 WARD DR.
SANTA BARBARA,  CA  93111
Applicant Contact LAURENS LICNTY
Correspondent
MCGHAN MEDICAL CORP.
700 WARD DR.
SANTA BARBARA,  CA  93111
Correspondent Contact LAURENS LICNTY
Classification Product Code
LCJ  
Date Received07/17/1985
Decision Date 09/18/1985
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
Recalls CDRH Recalls
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