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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 K981751
Device Name SINUSCOPE AND ACCESSORIES
Applicant
Henke Sass Wolf of America, Inc.
529 Ashland Ave.
Southbridge,  MA  01550
Applicant Contact ELLEN J HENKE
Correspondent
Henke Sass Wolf of America, Inc.
529 Ashland Ave.
Southbridge,  MA  01550
Correspondent Contact ELLEN J HENKE
Regulation Number874.4760
Classification Product Code
EOB  
Date Received05/18/1998
Decision Date 08/13/1998
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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