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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Implant, Transmandibular
510(k) Number K900433
Device Name SMOOTH STAPLE IMPLANT
Applicant
INTERPHASE IMPLANTS, INC.
19928 FARMINGTON RD.
LIVONIA,  MI  48152
Applicant Contact KNAPP DDS
Correspondent
INTERPHASE IMPLANTS, INC.
19928 FARMINGTON RD.
LIVONIA,  MI  48152
Correspondent Contact KNAPP DDS
Regulation Number872.4760
Classification Product Code
MDL  
Date Received01/30/1990
Decision Date 11/16/1990
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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