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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 K954991
Device Name PHASE CHANGE DENTAL LUBRICANT
Applicant
Phase Change
14325 N. 79th St.
Suite C
Scottsdale,  AZ  85260
Applicant Contact J. A GURNEY
Correspondent
Phase Change
14325 N. 79th St.
Suite C
Scottsdale,  AZ  85260
Correspondent Contact J. A GURNEY
Regulation Number872.4200
Classification Product Code
EFB  
Date Received10/31/1995
Decision Date 01/04/1996
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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