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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 K003422
Device Name EDTA ROOT CANAL CLEANSER
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 Received11/03/2000
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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