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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K032681
Device Name KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
Applicant
KONICA MEDICAL AND GRAPHIC CORPORATION
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN,  JP
Applicant Contact SHINICHI YAMANAKA
Correspondent
KONICA MEDICAL AND GRAPHIC CORPORATION
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN,  JP
Correspondent Contact SHINICHI YAMANAKA
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/29/2003
Decision Date 09/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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