Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K963335
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K963335
Device Name
Catheter, Intravascular, Diagnostic
Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO, NY 14211-1797 US
Other 510(k) Applications for this Company
Contact
JOSEPH KONIECZNY
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/1996
Decision Date
10/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact