Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993841
Device Classification Name
Cement Obturator
More FDA Info for this Device
510(K) Number
K993841
Device Name
Cement Obturator
Applicant
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
Other 510(k) Applications for this Company
Contact
DEBBIE DE LOS SANTOS
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
LZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/1999
Decision Date
05/04/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact