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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 K022038
Device Name SPI ONETIME DENTAL IMPLANT
Applicant
Paxmed International
4329 Graydon Rd.
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Paxmed International
4329 Graydon Rd.
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/24/2002
Decision Date 07/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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