ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER


Device Classification Name

accelerator, linear, medical

510(k) Number K021124
Device Name ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
Original Applicant
WFR/AQUAPLAST CORP.
30 lawlins park
wyckoff, 
NJ 
07481

Original Contact j damon kirk
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/08/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No