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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Detector, Ultraviolet
510(k) Number K770685
Device Name LIGHT, EXAMINING, DENTAL, ULTRA VIOLET
Applicant
Parker Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Parker Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6350
Classification Product Code
EAQ  
Date Received04/12/1977
Decision Date 04/26/1977
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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