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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Biopsy
510(k) Number K003370
Device Name JAMSHIDI MARROW ACQUISITION CRADLE
Applicant
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Applicant Contact LAVENIA FORD
Correspondent
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Correspondent Contact LAVENIA FORD
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/30/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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