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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K181193
Device Name PeriView FLEX
Applicant
Olympus Surgical Technologies America
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact Mary Anne Patella
Correspondent
Olympus Surgical Technologies America
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Mary Anne Patella
Regulation Number874.4680
Classification Product Code
KTI  
Date Received05/04/2018
Decision Date 07/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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