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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K191315
Device Name Remington Medical, Inc. Automatic Cutting Needle (NAC)
Applicant
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta,  GA  30005
Applicant Contact Caitlin Senter
Correspondent
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta,  GA  30005
Correspondent Contact Caitlin Senter
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/15/2019
Decision Date 07/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
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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