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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 K904671
Device Name QAR HANDPIECE
Applicant
Collagen Corp.
2500 Faber Pl.
Palo Alto,  CA  94303
Applicant Contact ROXANNE DUBOIS
Correspondent
Collagen Corp.
2500 Faber Pl.
Palo Alto,  CA  94303
Correspondent Contact ROXANNE DUBOIS
Regulation Number872.4200
Classification Product Code
EFB  
Date Received10/12/1990
Decision Date 12/21/1990
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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