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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 K953876
FOIA Releasable 510(k) K953876
Device Name PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
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 Number876.1500
Classification Product Code
ODG  
Date Received08/07/1995
Decision Date 11/24/1995
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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