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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K864540
Device Name PLAK VAK - PV-10
Applicant
Paul S. Barclay, D.D.S. , Ltd.
Suite 309
4801 W. Peterson Ave.
Chicago,  IL  60646
Applicant Contact BARCLAY, DDS
Correspondent
Paul S. Barclay, D.D.S. , Ltd.
Suite 309
4801 W. Peterson Ave.
Chicago,  IL  60646
Correspondent Contact BARCLAY, DDS
Regulation Number872.6510
Classification Product Code
EFS  
Date Received11/19/1986
Decision Date 07/02/1987
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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