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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 K924219
Device Name ENDOSSEOUS IMPLANTS
Applicant
The Stern Metals Co., Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact WALTON, JR.
Correspondent
The Stern Metals Co., Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact WALTON, JR.
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/21/1992
Decision Date 02/14/1994
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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