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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K081518
Device Name ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
Applicant
PENTAX MEDICAL COMPANY
102 CHESTNUT RIDGE RD.
MONTVALE,  NJ  07645 -1856
Applicant Contact PAUL SILVA
Correspondent
PENTAX MEDICAL COMPANY
102 CHESTNUT RIDGE RD.
MONTVALE,  NJ  07645 -1856
Correspondent Contact PAUL SILVA
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received05/30/2008
Decision Date 09/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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