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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 K904573
FOIA Releasable 510(k) K904573
Device Name PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact LORRAINE SCHWARTZ
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Correspondent Contact LORRAINE SCHWARTZ
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
FDS   FET  
Date Received10/09/1990
Decision Date 06/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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