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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 K943665
Device Name NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042 -1179
Applicant Contact BARRY E SANDS
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042 -1179
Correspondent Contact BARRY E SANDS
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/28/1994
Decision Date 10/11/1994
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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