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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 K031966
Device Name ENK FIBEROPTIC ATOMIZER SET
Applicant
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact JENNIFER J BOSLEY
Correspondent
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact JENNIFER J BOSLEY
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/26/2003
Decision Date 10/16/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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