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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K900135
Device Name CU-75 VISIBLE LIGHT-CURING UNIT
Applicant
Kab Gloves Unltd.
P.O. Box 725277
Berkley,  MI  48072
Applicant Contact KIRIT A BHATT
Correspondent
Kab Gloves Unltd.
P.O. Box 725277
Berkley,  MI  48072
Correspondent Contact KIRIT A BHATT
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/10/1990
Decision Date 05/07/1990
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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