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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K940864
Device Name DENTIST WITH ASSISTANT PACK
Applicant
Sterile Concepts, Inc.
5100 Commerce Rd..
Richmond,  VA  23234
Applicant Contact DARREN REEVES
Correspondent
Sterile Concepts, Inc.
5100 Commerce Rd..
Richmond,  VA  23234
Correspondent Contact DARREN REEVES
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/23/1994
Decision Date 08/02/1994
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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