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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name General Surgery Tray
510(k) Number K854292
Device Name MEDSURG ARTHROGRAM TRAY
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact DONNA COLLIER
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact DONNA COLLIER
Regulation Number878.4370
Classification Product Code
LRO  
Date Received10/25/1985
Decision Date 11/26/1985
Decision Substantially Equivalent (SESE)
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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