FDA 510(k) Application Details - K954161

Device Classification Name	Screen, Intensifying, Radiographic   More FDA Info for this Device
510(K) Number	K954161
Device Name	Screen, Intensifying, Radiographic
Applicant	JPI HEALTHCARE CO., LTD 41-02 BELL BLVD. SUITE LL3 BAYSIDE, NY 11361 US Other 510(k) Applications for this Company
Contact	KI M LEE Other 510(k) Applications for this Contact
Regulation Number	892.1960   More FDA Info for this Regulation Number
Classification Product Code	EAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/1995
Decision Date	02/02/1996
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