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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Coring (Huber) Needle
510(k) Number K211121
Device Name Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
Applicant
Intera Oncology, Inc.
65 Williams St., Suite 200
Wellesley,  MA  02481
Applicant Contact Michael Gaisford
Correspondent
Heyer Regulatory Solutions, LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number880.5570
Classification Product Code
PTI  
Date Received04/15/2021
Decision Date 10/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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