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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K960876
Device Name FIVE STAR BRONCHOSCOPE
Applicant
Five Star Medical, Inc.
Rr2 Box 418 Union Rd.
Holland,  MA  01521
Applicant Contact BEVERLY J STEWART
Correspondent
Five Star Medical, Inc.
Rr2 Box 418 Union Rd.
Holland,  MA  01521
Correspondent Contact BEVERLY J STEWART
Regulation Number874.4760
Classification Product Code
EOB  
Date Received03/04/1996
Decision Date 05/08/1996
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
Predetermined Change
Control Plan Authorized		 No
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