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 |
|
Date Received | 12/24/1986 |
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
|