FDA 510(k) Application Details - K980044

Device Classification Name	Light, Surgical, Floor Standing   More FDA Info for this Device
510(K) Number	K980044
Device Name	Light, Surgical, Floor Standing
Applicant	PERKINELMER OPTOELECTRONICS 35 CONGRESS ST. SALEM, MA 01970 US Other 510(k) Applications for this Company
Contact	ANTHONY STATUTO Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/1998
Decision Date	04/03/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review