Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K203193
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K203193
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD]
605 North 5600 West
Salt Lake City, UT 84116 US
Other 510(k) Applications for this Company
Contact
Connor Dahl
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2020
Decision Date
03/04/2021
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