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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spreader, Pulp Canal Filling Material, Endodontic
510(k) Number K853183
Device Name ENDODONTIC ELECTRONIC SPREADER HEATER
Applicant
Sturgeon Engineering Co.
1 Innovation Rd.
Petrolia,  CA  95558
Applicant Contact WILLIAM STURGEON
Correspondent
Sturgeon Engineering Co.
1 Innovation Rd.
Petrolia,  CA  95558
Correspondent Contact WILLIAM STURGEON
Regulation Number872.4565
Classification Product Code
EKK  
Date Received07/30/1985
Decision Date 10/16/1985
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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