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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Dental, With Operative Unit
510(k) Number K925567
Device Name E 4000 DENTAL OPERATING CHAIR
Applicant
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact WILLIAM A.LAMBERTSON
Correspondent
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact WILLIAM A.LAMBERTSON
Regulation Number872.6250
Classification Product Code
KLC  
Date Received11/03/1992
Decision Date 03/10/1994
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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