Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K991986
Device Classification Name
Apparatus, Autotransfusion
More FDA Info for this Device
510(K) Number
K991986
Device Name
Apparatus, Autotransfusion
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA, CO 80004 US
Other 510(k) Applications for this Company
Contact
LYNNE LEONARD
Other 510(k) Applications for this Contact
Regulation Number
868.5830
More FDA Info for this Regulation Number
Classification Product Code
CAC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/14/1999
Decision Date
09/09/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact