Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K960479
Device Classification Name
Electrode, Pacemaker, Temporary
More FDA Info for this Device
510(K) Number
K960479
Device Name
Electrode, Pacemaker, Temporary
Applicant
ARROW INTL., INC.
3000 BERNVILLE RD.
READING, PA 19605 US
Other 510(k) Applications for this Company
Contact
THOMAS D NICKEL
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
LDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/1996
Decision Date
10/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact