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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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