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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 K961974
Device Name FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
Applicant
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Applicant Contact PAUL SILVA
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
3117 COMMERCE PKWY.
MIRAMAR,  FL  33025
Correspondent Contact PAUL SILVA
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/20/1996
Decision Date 02/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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