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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K921354
Device Name BLUNT TIP IRRIGATION NEEDLES
Applicant
Innovators, Inc.
2721 D Industrial Dr.
Jefferson City,  MO  65109 -0771
Applicant Contact DON GENTRY
Correspondent
Innovators, Inc.
2721 D Industrial Dr.
Jefferson City,  MO  65109 -0771
Correspondent Contact DON GENTRY
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received03/20/1992
Decision Date 09/25/1992
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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