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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K041396
Device Name FG-36UX FIBER ULTRASOUND GASTROSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact PAUL SILVA
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
1279 QUARRY LANE, SUITE A
PLEASANTON,  CA  94566
Correspondent Contact MATTHIAS HEINZE
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
FDS  
Date Received05/26/2004
Decision Date 06/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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