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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 K946011
Device Name ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
Applicant
Argus Medical Co., Inc.
385 S. Lemon Ave.
Suite E-219
Walnut,  CA  91789
Applicant Contact WILLIAM MEYER
Correspondent
Argus Medical Co., Inc.
385 S. Lemon Ave.
Suite E-219
Walnut,  CA  91789
Correspondent Contact WILLIAM MEYER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/09/1994
Decision Date 02/17/1995
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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