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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K973430
Device Name KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact PHIL AMATO
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact PHIL AMATO
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/10/1997
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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