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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K920763
Device Name LACERATTION TRAY
Applicant
Sterile Concepts, Inc.
5100 Commerce Rd..
Richmond,  VA  23234
Applicant Contact KAY ANDREWS
Correspondent
Sterile Concepts, Inc.
5100 Commerce Rd..
Richmond,  VA  23234
Correspondent Contact KAY ANDREWS
Regulation Number878.4800
Classification Product Code
KDD  
Date Received02/19/1992
Decision Date 09/28/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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