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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K942672
Device Name STERI-LUBE
Applicant
Petroleum Products of America
7127 E. Becker Ln., #77
Scottsdale,  AZ  85254
Applicant Contact LEE HANNA
Correspondent
Petroleum Products of America
7127 E. Becker Ln., #77
Scottsdale,  AZ  85254
Correspondent Contact LEE HANNA
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/06/1994
Decision Date 07/06/1994
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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