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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K031789
Device Name EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact PAUL SILVA
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Correspondent Contact PAUL SILVA
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
FDS   FET  
Date Received06/10/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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