Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K001984
Device Classification Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
More FDA Info for this Device
510(K) Number
K001984
Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Applicant
STELKAST COMPANY
800 VINIAL ST. #210
PITTSBURGH, PA 15212 US
Other 510(k) Applications for this Company
Contact
DONALD A STEVENS
Other 510(k) Applications for this Contact
Regulation Number
888.3360
More FDA Info for this Regulation Number
Classification Product Code
JDG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/29/2000
Decision Date
09/27/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact