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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 K844123
Device Name RX CBY
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 Received10/23/1984
Decision Date 01/09/1985
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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