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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reamer, Pulp Canal, Endodontic
510(k) Number K770331
Device Name DIALYSIS, JET SYSTEM
Applicant
Janneck Ent. of Texas
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Janneck Ent. of Texas
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EKP  
Date Received02/17/1977
Decision Date 04/20/1977
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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