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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K943090
Device Name SUTURE REMOVAL TRAYS
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 Number880.6850
Classification Product Code
FRG  
Date Received06/28/1994
Decision Date 08/22/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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