FDA 510(k) Application Details - K974240

Device Classification Name	Collimator, Manual, Radiographic   More FDA Info for this Device
510(K) Number	K974240
Device Name	Collimator, Manual, Radiographic
Applicant	WUESTEC MEDICAL, INC. 421 HOLCOLMBE AVE. MOBILE, AL 36606 US Other 510(k) Applications for this Company
Contact	KRISTI WHITE Other 510(k) Applications for this Contact
Regulation Number	892.1610   More FDA Info for this Regulation Number
Classification Product Code	IZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1997
Decision Date	12/22/1997
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