MICRO-MAX, MODEL 319


codes

Device Classification Name

processor, radiographic-film, automatic

510(k) Number K002404
Device Name MICRO-MAX, MODEL 319
Original Applicant
TEK MARKETING, INC.
98 railroad dr.
warminster, 
PA 
18974 -1454

Original Contact john a hope
Regulation Number 892.1900
Classification Product Code
IXW  
Date Received 08/07/2000
Decision Date 08/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No