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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 -3935
Applicant Contact CHESTER MCCOY
Correspondent
ULTRADENT PRODUCTS, INC.
505 W. 10200 SO.
SOUTH JORDAN,  UT  84095 -3935
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
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