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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K862822
Device Name REXILLIUM N. B. F.
Applicant
Jeneric Ind.
125 N. Plains Indust. Rd.
P.O. Box 724
Wallingford,  CT  06492
Applicant Contact MARTIN L SCHULMAN
Correspondent
Jeneric Ind.
125 N. Plains Indust. Rd.
P.O. Box 724
Wallingford,  CT  06492
Correspondent Contact MARTIN L SCHULMAN
Regulation Number872.3710
Classification Product Code
EJH  
Date Received07/25/1986
Decision Date 09/02/1986
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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