Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K041239
Device Classification Name
Injector, Fluid, Non-Electrically Powered
More FDA Info for this Device
510(K) Number
K041239
Device Name
Injector, Fluid, Non-Electrically Powered
Applicant
GENESIS MEDICAL TECHNOLOGY, INC.
1555 EAST FLAMINGO ROAD
SUITE 155
LAS VEGAS, NV 89119 US
Other 510(k) Applications for this Company
Contact
THOMAS KROENKE
Other 510(k) Applications for this Contact
Regulation Number
880.5430
More FDA Info for this Regulation Number
Classification Product Code
KZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2004
Decision Date
11/08/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact