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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 K971278
Device Name PURE COMPANY FLUID DELIVERY SYSTEM
Applicant
Pure Co.
2045 Preisker Ln.
Santa Maria,  CA  93454
Applicant Contact GARY S NUNNELLY
Correspondent
Pure Co.
2045 Preisker Ln.
Santa Maria,  CA  93454
Correspondent Contact GARY S NUNNELLY
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/07/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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