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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K962302
Device Name PEGASUS DENTAL ALLOY
Applicant
Sterngold/Implamed
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Applicant Contact NICHOLAS J SAVARESE
Correspondent
Sterngold/Implamed
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Correspondent Contact NICHOLAS J SAVARESE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received06/17/1996
Decision Date 07/18/1996
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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