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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 K023376
Device Name EB-1830T3, VIDEO BRONCHOSCOPE
Applicant
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact PAUL SILVA
Correspondent
Pentax Precision Instrument Corp.
30 Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact PAUL SILVA
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/08/2002
Decision Date 10/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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