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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 K865056
Device Name CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER
Applicant
COX-UPHUFF INTL.
P.O. BOX 40288
SANTA BARBARA,  CA  93140
Applicant Contact DAVID J SCHUESSLER
Correspondent
COX-UPHUFF INTL.
P.O. BOX 40288
SANTA BARBARA,  CA  93140
Correspondent Contact DAVID J SCHUESSLER
Classification Product Code
LCJ  
Date Received12/24/1986
Decision Date 05/22/1987
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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