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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K883322
Device Name DENTAL HAND INSTRUMENTS
Applicant
Collagen Corp.
2500 Faber Pl.
Palo Alto,  CA  94303
Applicant Contact ROBIN BUSH
Correspondent
Collagen Corp.
2500 Faber Pl.
Palo Alto,  CA  94303
Correspondent Contact ROBIN BUSH
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received08/05/1988
Decision Date 08/26/1988
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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