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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Biopsy Needle
510(k) Number K834249
Device Name MONOJECT SOFT TISSUE BIOPSY NEEDLE
Applicant
SHERWOOD MEDICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHERWOOD MEDICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/07/1983
Decision Date 03/12/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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