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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Dental
510(k) Number K864970
Device Name TERUMO DENTAL NEEDLES
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact HARALD JACOBY
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact HARALD JACOBY
Regulation Number872.4730
Classification Product Code
DZM  
Date Received12/22/1986
Decision Date 03/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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