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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 K001638
Device Name O-RING PROSTHETIC ATTACHMENT
Applicant
Titan Implants
203 Main St.
Pmb 166
Flemington,  NJ  08822
Applicant Contact LYNETTE L HOWARD
Correspondent
Titan Implants
203 Main St.
Pmb 166
Flemington,  NJ  08822
Correspondent Contact LYNETTE L HOWARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/30/2000
Decision Date 03/04/2002
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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