FDA 510(k) Application Details - K955158

Device Classification Name	Apparatus, Cautery, Radiofrequency, Ac-Powered   More FDA Info for this Device
510(K) Number	K955158
Device Name	Apparatus, Cautery, Radiofrequency, Ac-Powered
Applicant	ELLMAN INTL., INC. 30 NORTHPORT RD. SOUND BEACH, NY 11789-1734 US Other 510(k) Applications for this Company
Contact	RICHARD C LANZILLOTTO Other 510(k) Applications for this Contact
Regulation Number	886.4100   More FDA Info for this Regulation Number
Classification Product Code	HQR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/1995
Decision Date	02/09/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review