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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Subperiosteal
510(k) Number K801208
Device Name HOLLOW BASKET TITANIUM DENTAL IMPLANT
Applicant
Colmed, Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Colmed, Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3645
Classification Product Code
ELE  
Date Received05/20/1980
Decision Date 05/28/1980
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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