Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113644
Device Classification Name
Cuff, Tracheal Tube, Inflatable
More FDA Info for this Device
510(K) Number
K113644
Device Name
Cuff, Tracheal Tube, Inflatable
Applicant
INSTRUMENTATION INDUSTRIES, INC.
2990 INDUSTRIAL BLVD.
BETHEL PARK, PA 15102 US
Other 510(k) Applications for this Company
Contact
DORIS F WALTER
Other 510(k) Applications for this Contact
Regulation Number
868.5750
More FDA Info for this Regulation Number
Classification Product Code
BSK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2011
Decision Date
01/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact