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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 K152531
Device Name InstaClear Lens Cleaner
Applicant
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Applicant Contact DOLAN MILLS
Correspondent
Gyrus Acmi, Inc.
136 Turnpike Rd.
Southborough,  MA  01772
Correspondent Contact DOLAN MILLS
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/03/2015
Decision Date 01/15/2016
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
Recalls CDRH Recalls
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