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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K992919
Device Name OXY-GLIDE ROOT CANAL CLEANSER & LUB.
Applicant
Super Glide, Inc.
227 Colchester Ave.
Burlington,  VT  05401
Applicant Contact VICTOR L RATKUS
Correspondent
Super Glide, Inc.
227 Colchester Ave.
Burlington,  VT  05401
Correspondent Contact VICTOR L RATKUS
Classification Product Code
KJJ  
Date Received08/30/1999
Decision Date 11/19/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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