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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name curette, uterine
510(k) Number K901442
Device Name BAXTER D & C TRAY
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 Number884.4530
Classification Product Code
HCY  
Date Received03/27/1990
Decision Date 07/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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