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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 K013731
Device Name GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
Applicant
GIMMI GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Applicant Contact DAGMAR S MASER
Correspondent
GIMMI GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Correspondent Contact DAGMAR S MASER
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
EOB  
Date Received11/09/2001
Decision Date 11/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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