Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K061767
Device Classification Name
More FDA Info for this Device
510(K) Number
K061767
Device Name
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
Applicant
Z-MEDICA CORPORATION
4 FAIRFIELD BLVD.
WALLINGFORD, CT 06492 US
Other 510(k) Applications for this Company
Contact
ROBERT V PACKARD
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/23/2006
Decision Date
07/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact