BIOFLEX LD-R100 TREATMENT HEAD


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K081355
Device Name BIOFLEX LD-R100 TREATMENT HEAD
Applicant
MEDITECH INTERNATIONAL, INC.
411 horner ave., unit #1
toronto, ontario, 

CA

m8w 4w3

Applicant Contact fred kahn
Correspondent
MEDITECH INTERNATIONAL, INC.
411 horner ave., unit #1
toronto, ontario, 

CA

m8w 4w3

Correspodent Contact fred kahn
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 05/14/2008
Decision Date 12/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No