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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Light, Operating, Dental
510(k) Number K925629
Device Name ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
Applicant
Den-Tal-Ez Mfg Co., Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact WILLIAM A.LAMBERTSON
Correspondent
Den-Tal-Ez Mfg Co., Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact WILLIAM A.LAMBERTSON
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received11/06/1992
Decision Date 11/23/1993
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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