Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K090383
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K090383
Device Name
Gown, Surgical
Applicant
SRI SURGICAL
12425 RACE TRACK RD.
TAMPA, FL 33626 US
Other 510(k) Applications for this Company
Contact
NISSA MULNICK
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
02/17/2009
Decision Date
05/29/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact