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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 K853478
Device Name PINPOINT NEEDLE
Applicant
REGIONAL MASTER CORP.
P.O. BOX 431832
MIAMI,  FL  33143
Applicant Contact MARGARITA PLAZA
Correspondent
REGIONAL MASTER CORP.
P.O. BOX 431832
MIAMI,  FL  33143
Correspondent Contact MARGARITA PLAZA
Regulation Number868.5150
Classification Product Code
BSP  
Date Received08/14/1985
Decision Date 01/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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