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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 K862203
Device Name MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER
Applicant
MCGHAN MEDICAL CORP.
700 WARD DR.
SANTA BARBARA,  CA  93111
Applicant Contact LAURENS LICHTY
Correspondent
MCGHAN MEDICAL CORP.
700 WARD DR.
SANTA BARBARA,  CA  93111
Correspondent Contact LAURENS LICHTY
Classification Product Code
LCJ  
Date Received06/10/1986
Decision Date 07/23/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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