FDA 510(k) Application Details - K993089

Device Classification Name	Light, Surgical, Accessories   More FDA Info for this Device
510(K) Number	K993089
Device Name	Light, Surgical, Accessories
Applicant	DEROYAL CARDIOVASCULAR, INC. 200 DEBUSK LN. POWELL, TN 37849 US Other 510(k) Applications for this Company
Contact	LOIS MARSH Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/1999
Decision Date	10/14/1999
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