DRYSTAR 5500


Device Classification Name

camera, multi format, radiological

510(k) Number K023287
Device Name DRYSTAR 5500
Original Applicant
AGFA CORP.
10 south academy st.
greenville, 
SC 
29601

Original Contact jeff jedlicka
Regulation Number 892.2040
Classification Product Code
LMC  
Date Received 10/02/2002
Decision Date 10/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No