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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K190715
Device Name EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
Applicant
Interscope, Inc.
100 Main Street, Suite 108
Whitinsville,  MA  01588
Applicant Contact Jeffery Ryan
Correspondent
ICON Clinical Research, LLC
2100 Pennbrook Parkway
North Wales,  PA  19454
Correspondent Contact Cynthia Nolte
Regulation Number874.4250
Classification Product Code
ERL  
Date Received03/19/2019
Decision Date 12/13/2019
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
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