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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 K854816
Device Name EPIDURAL ANESTHESIA NEEDLES
Applicant
REGANES, INC.
P.O. BOX 13212
CLEARWATER,  FL  33519
Applicant Contact JOSEPH E HARMS
Correspondent
Spectra Medical Devices, Inc
299 Ballardvale St., Suite I,
Wilmington,  MA  01887
Correspondent Contact Kathy Dassler
Regulation Number868.5150
Classification Product Code
BSP  
Date Received12/03/1985
Decision Date 12/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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