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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 K924468
Device Name STERILE INSTRUMENT TRAYS/BASIN SETS
Applicant
BAXTER HEALTHCARE CORP.
7280 NORTH CALDWELL
NILES,  IL  60648
Applicant Contact LAJUAN MCGILL
Correspondent
BAXTER HEALTHCARE CORP.
7280 NORTH CALDWELL
NILES,  IL  60648
Correspondent Contact LAJUAN MCGILL
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/02/1992
Decision Date 07/09/1993
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
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