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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 K882226
Device Name SERIES I AND II IMPLANTS
Applicant
Saber Technology, Inc.
720 Olive Way
Suite 810
Seattle,  WA  98101
Applicant Contact SAPKOS, DDS
Correspondent
Saber Technology, Inc.
720 Olive Way
Suite 810
Seattle,  WA  98101
Correspondent Contact SAPKOS, DDS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/26/1988
Decision Date 08/29/1988
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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