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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K943370
Device Name IMPULSE SEALER PRODUCT LINE
Applicant
Ultradent Products, Inc.
505 W. 10200 So.
South Jordan,  UT  84095 -3935
Applicant Contact L.M. CHATWIN
Correspondent
Ultradent Products, Inc.
505 W. 10200 So.
South Jordan,  UT  84095 -3935
Correspondent Contact L.M. CHATWIN
Regulation Number872.6770
Classification Product Code
EJI  
Date Received07/13/1994
Decision Date 10/21/1994
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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