FDA 510(k) Application Details - K980526

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K980526
Device Name	System, Therapeutic, X-Ray
Applicant	PEC PHOTOELECTRON CORP. 5 FORBES RD. LEXINGTON, MA 02173 US Other 510(k) Applications for this Company
Contact	THOMAS R VARRICCHIONE 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	02/10/1998
Decision Date	07/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review