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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K150266
Device Name Remington Medical Inc. Tuohy Epidural Needles
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 Number868.5150
Classification Product Code
BSP  
Date Received02/04/2015
Decision Date 06/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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