FDA 510(k) Application Details - K973315

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K973315
Device Name	System, Therapeutic, X-Ray
Applicant	PANTAK, INC. 31 BUSINESS PARK DR. BRANFORD, CT 06405 US Other 510(k) Applications for this Company
Contact	GREG MOREAU Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/1997
Decision Date	12/02/1997
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