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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K901600
Device Name OSSEOTITE IRRIGATION UNIT
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 Number872.6510
Classification Product Code
EFS  
Date Received04/06/1990
Decision Date 06/21/1990
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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