Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961802
Device Classification Name
Strip, Craniosynostosis, Preformed
More FDA Info for this Device
510(K) Number
K961802
Device Name
Strip, Craniosynostosis, Preformed
Applicant
W.L. GORE & ASSOCIATES,INC
301 AIRPORT RD
ELKTON, MD 21922-1408 US
Other 510(k) Applications for this Company
Contact
JOHN W NICHOLSON
Other 510(k) Applications for this Contact
Regulation Number
882.5900
More FDA Info for this Regulation Number
Classification Product Code
GXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/1996
Decision Date
07/31/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact