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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K981596
Device Name ULTRAPAK E
Applicant
Ultradent Products, Inc.
505 W. 10200 So.
South Jordan,  UT  84095
Applicant Contact CHESTER MCCOY
Correspondent
Ultradent Products, Inc.
505 W. 10200 So.
South Jordan,  UT  84095
Correspondent Contact CHESTER MCCOY
Classification Product Code
MVL  
Date Received05/04/1998
Decision Date 07/31/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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