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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 K913348
Device Name THE STERN ERA SYSTEM
Applicant
Sterngold/Implamed
C/O Medical Device Conultants
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact FRANK S CASCIANI
Correspondent
Sterngold/Implamed
C/O Medical Device Conultants
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact FRANK S CASCIANI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/26/1991
Decision Date 01/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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