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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K901672
Device Name RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT
Applicant
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Applicant Contact JAMES R GRIEGER
Correspondent
Pelton & Crane Co.
P.O. Box 7800
Charlotte,  NC  28241
Correspondent Contact JAMES R GRIEGER
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/10/1990
Decision Date 07/06/1990
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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