Device Classification Name |
Expander, Surgical, Skin Graft
|
510(k) Number |
K984448 |
Device Name |
BIRCOLL BALLOON DISSECTOR |
Applicant |
WELLS JOHNSON CO. |
8000 SOUTH KOLB RD. |
TUCSON,
AZ
85706
|
|
Applicant Contact |
KEN RODENBURG |
Correspondent |
WELLS JOHNSON CO. |
8000 SOUTH KOLB RD. |
TUCSON,
AZ
85706
|
|
Correspondent Contact |
KEN RODENBURG |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/14/1998 |
Decision Date | 01/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|