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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K944139
Device Name DENTAL HYGIENE TRAY
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 Number880.6250
Classification Product Code
LYY  
Date Received08/24/1994
Decision Date 12/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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