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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 K944976
Device Name BRONCHOSCOPE,NON-RIGID
Applicant
Citation Medical Corp.
230 Edison Way
Reno,  NV  89502
Applicant Contact GEORGE MIDDLE
Correspondent
Citation Medical Corp.
230 Edison Way
Reno,  NV  89502
Correspondent Contact GEORGE MIDDLE
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/11/1994
Decision Date 12/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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