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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K905614
Device Name JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
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 Number878.4200
Classification Product Code
GBX  
Date Received12/14/1990
Decision Date 03/20/1991
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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