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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K932529
Device Name LIGHTSPEED DENTAL HAND INSTRUMENT
Applicant
Lightspeed Endodontics
5832 Auden
Houston,  TX  77005
Applicant Contact STEVE SENIA
Correspondent
Lightspeed Endodontics
5832 Auden
Houston,  TX  77005
Correspondent Contact STEVE SENIA
Regulation Number872.4565
Classification Product Code
EKS  
Date Received05/25/1993
Decision Date 11/04/1993
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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