Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K981880
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K981880
Device Name
System, X-Ray, Stationary
Applicant
WUESTEC MEDICAL, INC.
5600 COMMERCE BLVD., EAST
MOBILE, AL 36619-0037 US
Other 510(k) Applications for this Company
Contact
DAVID ANDRESS
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/1998
Decision Date
10/20/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact