Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093835
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K093835
Device Name
Gown, Surgical
Applicant
BAM CORP., LTD.
UNIT 1706, TOWER 2, GRAND CNTL
PLAZA, NO.138 SHATIN RURAL
COMMITTEE RD.,SHATIN, N.T. HK
Other 510(k) Applications for this Company
Contact
MARY MEJAES
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2009
Decision Date
02/04/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact