FDA 510(k) Application Details - K951033

Device Classification Name	Pack, Hot Or Cold, Disposable   More FDA Info for this Device
510(K) Number	K951033
Device Name	Pack, Hot Or Cold, Disposable
Applicant	CANDELA LASER CORP. 530 BOSTON POST RD. WAYLAND, MA 01778 US Other 510(k) Applications for this Company
Contact	THOMAS R VARRICCHIONE Other 510(k) Applications for this Contact
Regulation Number	890.5710   More FDA Info for this Regulation Number
Classification Product Code	IMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/1995
Decision Date	08/15/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review