Device Classification Name |
Gown, Surgical
|
510(k) Number |
K093835 |
Device Name |
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN |
Applicant |
BAM CORP., LTD. |
UNIT 1706, TOWER 2, GRAND CNTL |
PLAZA, NO.138 SHATIN RURAL |
COMMITTEE RD.,SHATIN, N.T.,
HK
|
|
Applicant Contact |
MARY MEJAES |
Correspondent |
BAM CORP., LTD. |
UNIT 1706, TOWER 2, GRAND CNTL |
PLAZA, NO.138 SHATIN RURAL |
COMMITTEE RD.,SHATIN, N.T.,
HK
|
|
Correspondent Contact |
MARY MEJAES |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 12/15/2009 |
Decision Date | 02/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|