RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS


Device Classification Name

accelerator, linear, medical

510(k) Number K991319
Device Name RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
Applicant
ORFIT INDUSTRIES
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact cynthia nolte
Correspondent
ORFIT INDUSTRIES
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact cynthia nolte
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/19/1999
Decision Date 09/21/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized