Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K103011
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K103011
Device Name
Syringe, Antistick
Applicant
ULTI-MED INTL., INC.
5353 WAYZATA BOULEVARD
SUITE 505
MINNEAPOLIS, MN 55416 US
Other 510(k) Applications for this Company
Contact
MARY BETH HENDERSON
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
MEG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/12/2010
Decision Date
02/02/2011
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