FDA 510(k) Application Details - K981954

Device Classification Name Blade-Form Endosseous Dental Implant

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510(K) Number K981954
Device Name Blade-Form Endosseous Dental Implant
Applicant HEALTHLINE IMPLANTS, INC.
832 MARSEILLES-GALION RD W
MARION, OH US
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Contact WILLIAM SIMMONS
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Regulation Number 872.3640

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Classification Product Code NRQ
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Date Received 06/04/1998
Decision Date 01/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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