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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K904228
Device Name OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)
Applicant
Collagen Corp.
2500 Faber Place
Palo Alto,  CA  94303
Applicant Contact ROXANNE DUBOIS
Correspondent
Collagen Corp.
2500 Faber Place
Palo Alto,  CA  94303
Correspondent Contact ROXANNE DUBOIS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/14/1990
Decision Date 11/09/1990
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
Recalls CDRH Recalls
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