ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT


Device Classification Name

powered laser surgical instrument

510(k) Number K112600
Device Name ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
Applicant
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Applicant Contact teri juckett
Correspondent
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Correspodent Contact teri juckett
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 09/07/2011
Decision Date 01/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No